MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS AXIS PIN; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6366-9-220
Medical Device Problem Codes	Material Erosion (1214); 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.
Additional Manufacturer Narrative
An event regarding wear involving a hmrs axle was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is worn along the circumference of the barrel.Damage appears consistent with contact against a hard object.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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 the device is worn along the circumference of the barrel.Damage appears consistent with contact against a hard object.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.
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.

• Brand Name: HMRS AXIS PIN
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13767288
• Report Number: 0002249697-2022-00395
• Device Sequence Number: 5008706
• Product Code: KRO
• UDI-Device Identifier: 07613327049930
• UDI-Public: 07613327049930
• 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): 09/15/2022

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: 06/30/2013
• Device Model Number: 6366-9-220
• Device Catalogue Number: 63669220
• Device Lot Number: CTD145A
• 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: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2008
• 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: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male