MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS SMALL FEMORAL BUSHING; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6495-2-105
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	07/18/2022
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
It was reported that the surgeon revised the axle bushings and bumper as a result of excessive wear.
Event or Problem Description
It was reported that the surgeon revised the axle bushings and bumper as a result of excessive wear.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a gmrs bushing was reported.The event was confirmed via evaluation of the returned device.Method & results: -device evaluation and results: the device was returned for evaluation.Blood and yellow discoloration is visible on the device.The damage present on the polyethylene devices appears consistent with delamination and material loss.The damage to the bushings and bumper is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed is consistent with the absorption of synovial fluid by the device.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pi including the product inquiry summary, and an ap and lateral view x-rays of a dmrs tka.The event description from the product inquiries summary states: it was reported that the surgeon revised the axle bushings and bumper as a result of excessive wear.The ap and lateral x-rays show a cemented gmrs tka in good position without evidence of mechanical complication.The limited documentation does not provide confirming evidence of a mechanical complication i.E., wear of the bushings and axle.As such the root cause for this cannot be determined.Should additional information become available i would be happy to further this assessment.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: an event regarding wear was reported.The device was returned for evaluation.Blood and yellow discoloration is visible on the device.The damage present on the polyethylene devices appears consistent with delamination and material loss.The damage to the bushings and bumper is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed is consistent with the absorption of synovial fluid by the device.A review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pi including the product inquiry summary, and an ap and lateral view x-rays of a dmrs tka.The event description from the product inquiries summary states: it was reported that the surgeon revised the axle bushings and bumper as a result of excessive wear.The ap and lateral x-rays show a cemented gmrs tka in good position without evidence of mechanical complication.The limited documentation does not provide confirming evidence of a mechanical complication i.E., wear of the bushings and axle.As such the root cause for this cannot be determined.Should additional information become available i would be happy to further this assessment.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: GMRS SMALL FEMORAL BUSHING
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15188306
• Report Number: 0002249697-2022-01155
• Device Sequence Number: 5847716
• Product Code: KRO
• UDI-Device Identifier: 07613327048841
• UDI-Public: 07613327048841
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: 6495-2-105
• Device Catalogue Number: 64952105
• 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): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 11/07/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown