MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN LEGACY POSTERIOR STABILIZED FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Metal Shedding Debris (1804); Scratched Material (3020); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Reaction (2414)

Event Date 04/18/2016

Event Type  Injury  

Manufacturer Narrative

Information was received from a foreign source who is not required to complete form 3500a.The following sections could not be completed with the limited information provided.Date implanted - ni event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure occurred.Should additional information be received regarding the revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.

Event Description

It was reported that the patient was revised due to pain 8 years post operatively.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported the patient underwent a total knee arthroplasty.Subsequently, the patient underwent a revision procedure approximately eight years post-implantation due to pain and limited motion.The patient was also unable to ride a bicycle or driver a car.During the revision, the surgeon noted heavy metallosis.In addition, there was damage on both condyles and two symmetrical grooves on the femoral component.

• Brand Name: NEXGEN LEGACY POSTERIOR STABILIZED FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6121046
• MDR Text Key: 60676617
• Report Number: 0001822565-2016-04008
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PK991581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 00599601602
• Device Lot Number: 60209071
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 65