MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER UNICOMPARTMENTAL KNEE ARTICULAR SURFACE; KNEE PROSTHESIS

Catalog Number 00584202308

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the articular surface made an audible click on insertion and was fully seated on the anterior edge, however the lateral edge was sitting up 1 ¿ 2mm not fully seated.The device was removed and the knee arthroplasty surgery was completed with a different articular surface.

Manufacturer Narrative

This report will be amended when our investigation is complete.Returned, not yet evaluated.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed as the returned device exhibits damage to locking surface and gauging on the surface.Visual inspection of the returned art surface identified damage to the locking feature.The implant was gauged on the surface, this could have happened as several attempts were made by the surgeon to seat the implant.Measured dimensions were found conforming to print specifications.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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.

• Brand Name: ZIMMER UNICOMPARTMENTAL KNEE ARTICULAR SURFACE
• Type of Device: KNEE PROSTHESIS
• 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: 6000882
• MDR Text Key: 56498445
• Report Number: 0001822565-2016-03539
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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
• Report Date: 06/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 00584202308
• Device Lot Number: 63200793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/20/2016; 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• 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 Age: 66 YR
• Patient Weight: 80