NexGen Knee Adverse Events from FDA Reports in the FDA MAUDE Database

While there are hundreds of NexGen knee implant reports in the database, here are but a few reports in the FDA MAUDE database at random.

---

Device Problems Fracture; Noise; Implant, removal of
Event Date 11/30/2010
Event Type Injury - Patient Outcome Required Intervention

Event Description
It is reported that the patient presented himself to surgeon complaining of a clicking sound and catching of his left knee. Upon performing a scope for a loose body, it was discovered that the post of the articular surface had fractured. The knee was opened and the articular surface was replaced.

---

Device Problems Explanted; Loose
Event Date 12/01/2010
Event Type Injury - Patient Outcome Required Intervention
Manufacturer Narrative
Info was received from a health professional not required to complete form 3500a. This report will be amended when our investigation is complete.

Event Description
It is reported that the patient was revised for tibial baseplate loosening.

---

Device Problems Explanted; Loose
Event Date 02/24/2010
Event Type Injury - Patient Outcome Required Intervention
Event Description
It is reported that the patient was revised for tibial baseplate loosening, pain, and lysis.

Manufacturer Narrative
Eval summary: review of surgical reports provided indicates surgical technique was followed. There are no returned products or x-rays available to study the implantation technique. Without return of product and/or x-rays, a probable cause for alleged deficiency or pain cannot be determined. Eval: review of the device history records did not find any deviations or anomalies. It is not suspected that the product failed to meet specifications. The investigation could not verify or identify any evidence of product contribution to the reported problem. Based on the investigation, the need for corrective action is not indicated. Should additional substantive info be received, the complaint will be reopened. Zimmer, inc. Considers the investigation closed.

---

Device Problem Fracture 
Event Date 01/26/2010
Event Type Malfunction   

Manufacturer Narrative 
As returned, the impactor pad contains nicks and gouges. The handle also exhibits heavy usage from the damage on the impaction site. This failure has been previously characterized by development. Impactors become damaged through repeated use due to impactions sustained while in use. Impactors or impactor heads should be replaced when the part is no longer functioning. The instrument was found to meet print specs and the device history records were reviewed and found to be conforming. The instrument had a potential field age of approx 39 months at the time of return. The cause of failure appears to be normal wear and tear.

Event Description 
It is reported that upon final impaction of cemented tibial base plate, black particles appeared a dust-like in wound and around wound. With further inspection, it was apparent that the black portion of tibial impactor had chipped off. The surgeon thoroughly irrigated wound to his satisfaction. No further recourse is expected per surgeon.

---

Device Problem Fracture 
Event Date 03/11/2010
Event Type - Malfunction 

Event Description 
It is reported that when cementing the tibial, the surgeon detected a piece of metal in the patient's knee. The metal piece belonged to the handhold of the rasp. It must have broken off during preparation of the tibia.
Manufacturer Narrative 
This report will be amended when our investigation is complete.

---

Device Problem Explanted 
Event Date 11/16/2010
Event Type Injury - Patient Outcome Required Intervention;

Manufacturer Narrative 
This report will be amended when our investigation is complete.
Event Description 
It is reported that the patient was revised because of various mal-alignment issues. The device was implanted in 2005.

Are these similar to problems you have had? 

Do you want to report your problems to the FDA? Has your surgeon reported a Zimmer knee replacement problem to the FDA?

Find out how a lawsuit might help shed light on the problems you have experienced, help provide information that could lead to a recall of the particular NexGen product known as a NexGen CR Flex cementless femoral component, and could compensate you for your pain and suffering from a potentially defective medical device.

Talk to a Lawyer