MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS WEDGE - 7 X 18; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6465-6-007
Medical Device Problem Codes	Degraded (1153); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Hyperextension (4523); Joint Laxity (4526)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following was reported: revision (hmrs parts replacement).After 23 years, the poly is worn out.It is manifested by hyperextension of the knee joint and marked instability.The distal femur shows signs of wear, which shows up as metallosis in the knee joint."now after the revision surgery everything was fine again.".
Additional Manufacturer Narrative
Reported event: an event regarding wear and instability involving a hmrs bumper was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that some scratch marks were observed on the surface.The device is also fractured but this is likely due to the explantation attempt.Dimensional inspection: dimensional inspection was not performed because the device was returned damaged.Functional inspection: functional inspection was not performed because the device was returned damaged.Material analysis: there is no indication that the event was a result of a material integrity issue.If further information becomes available additional testing will be performed.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to wear of the components.Visual inspection of the returned device indicated that some scratch marks were observed on the surface.The device is also fractured but this is likely due to the explantation attempt.There is no indication that the event was a result of a material integrity issue.If further information becomes available additional testing will be performed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary/revision operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The following was reported: revision (hmrs parts replacement).After 23 years, the poly is worn out.It is manifested by hyperextension of the knee joint and marked instability.The distal femur shows signs of wear, which shows up as metallosis in the knee joint."now after the revision surgery everything was fine again.".

• Brand Name: HMRS WEDGE - 7 X 18
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14073862
• Report Number: 0002249697-2022-00511
• Device Sequence Number: 12296448
• Product Code: KRO
• UDI-Device Identifier: 07613327048933
• UDI-Public: 07613327048933
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2003
• Device Model Number: 6465-6-007
• Device Catalogue Number: 64656007
• Device Lot Number: LF8W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 09/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/1998
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female