MAUDE Adverse Event Report: ZIMMER INC NEXGEN COMPLETE KNEE SOLUTION LEGACY; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number 5964-40-14

Device Problems Break (1069); Device Slipped (1584); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2015

Event Type  malfunction  

Event Description

Orthopedic surgeon attempted to use the zimmer tibial 12mm poly insert but the device would not seat properly.When the device was removed and closely inspected by the surgeon he noted that the lip of the poly insert on the underside was damaged.The company rep agreed that there was as a defective area on the articular surface.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION LEGACY
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): ZIMMER INC; 345 east main street; warsaw, IN 46580
• MDR Report Key: 5090391
• MDR Text Key: 26264331
• Report Number: 5090391
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: 5964-40-14
• Device Lot Number: 63017541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO