MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER UNICOMPARTMENTAL KNEE HIGH FLEX PRECOAT FEMORAL COMPONENT; KNEE PROSTHESIS

Catalog Number 00584201501

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/05/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that after undergoing knee arthroplasty, the patient is experiencing a fracture of the femoral component and articular surface component abrasion wear.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is now known that the patient underwent knee arthroplasty revision due to previously reported issues.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Complaint samples were evaluated and the reported event was confirmed.Inspection of the femoral component revealed the condlye is fractured and there is foreign debris and scratches on its surface.The scratches likely occurred during extraction.Dimensional analysis of the femoral component found it conformed to specification.Sem analysis of condyle fracture indicated it was likely caused by fatigue.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.A summary of the investigation will be sent to the complainant.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.

Event Description

No additional information reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Visual examination for the returned product found evidence of being implanted.The articular surface is extremely worn and fractured/cracked.The femoral condyle is fractured and all pieces were not returned.There is cement seen on part of the femoral component, however as product information for the cement and information of the cement technique used was not provided a definitive statement cannot be made.There is a lack of bone ingrowth seen on the femoral component which could indicate loosening.Device was submitted for further analysis.Analysis determined the femoral condyle fractured due to fatigue.Eds semi-quantitative elemental analysis of the fracture showed that it was consistent with co-cr-mo alloy.Review of complaint history identified additional similar complaints for the reported items and no additional complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Implant fracture and poly wear were confirmed; however, it is unknown whether the implant fracture or loosening occurred first.The loosening has not been confirmed therefore this complaint cannot be confirmed.

Event Description

Investigation updated.

• Brand Name: ZIMMER UNICOMPARTMENTAL KNEE HIGH FLEX PRECOAT FEMORAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• MDR Report Key: 5986580
• MDR Text Key: 55896289
• Report Number: 0001822565-2016-03429
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: PK033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 00584201501
• Device Lot Number: 61968545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2016
• Initial Date FDA Received: 09/29/2016
• Supplement Dates Manufacturer Received: Not provided; 09/08/2017; 02/21/2020; 07/27/2020
• Supplement Dates FDA Received: 10/21/2016; 10/05/2017; 03/19/2020; 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention