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); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2022
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.Device not returned.
Event or Problem Description
Hmrs parts replacement after 12 years.The wear of the components was confirmed during the surgery.The parts have all been replaced as requested.Some poly parts were severely damaged or disassembled into individual parts due to the difficult disassembly.Due to wear and tear, it was suspected that replacing the components would be prudent.
Event or Problem Description
Hmrs parts replacement after 12 years.The wear of the components was confirmed during the surgery.The parts have all been replaced as requested.Some poly parts were severely damaged or disassembled into individual parts due to the difficult disassembly.Due to wear and tear, it was suspected that replacing the components would be prudent.
Additional Manufacturer Narrative
Reported event: an event regarding wear 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 the device is severely damaged.The device has been fractured into at least two pieces.Damage is consistent with what was reported in the event description "some poly parts were severely damaged or disassembled into individual parts due to the difficult disassembly." due to the damage sustained from the explantation attempt, no comments can be made regarding wear.Material analysis: material analysis was not performed as the device was returned damaged from the explantation attempt, as reported in the event.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to wear of the components.Visual inspection of the returned device indicated that the device is severely damaged.The device has been fractured into at least two pieces.Damage is consistent with what was reported in the event description "some poly parts were severely damaged or disassembled into individual parts due to the difficult disassembly." due to the damage sustained from the explantation attempt, no comments can be made regarding wear.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.It was reported that the patient was very active post-implantation.The patient's activity level may have contributed to the reported failure of the devices.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.

• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13767231
• Report Number: 0002249697-2022-00393
• Device Sequence Number: 17151034
• 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: 2009
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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 Model Number: 6465-6-007
• Device Catalogue Number: 64656007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 60 YR
• Patient Sex: Male