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

Catalog Number	64952105
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left knee was revised due to wear of the poly component.Possible cause or contributor for wear not reported.Patient's activity level is unknown.Patient was revised to poly component of the same catalog number.Rep reported that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's left knee was revised due to wear of the poly component.Possible cause or contributor for wear not reported.Patient's activity level is unknown.Patient was revised to poly component of the same catalog number.Rep reported that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
N event regarding wear involving a mrh bushing reported.The event was confirmed by mar review.Method & results: - product evaluation and results: - visual inspection: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2019 which indicated the femoral bushings and the bumper insert contain damage and material loss on both the femoral bushings and the bumper insert are consistent with contact against a hard object.Discoloration of the femoral bushings and bumper insert are consistent with synovial fluid absorption.Delamination also occurred on the femoral bushings, which is a common damage mode of uhmwpe.Significant wear was observed on the proximal portion of the bumper insert.This wear resulted in the loss of material which potentially enabled the femoral component to contact the tibial component.The examination of the femoral component would be required to confirm this interaction.-dimensional inspection: not performed as the device was returned in damage condition.-functional inspection: not performed as the device was returned in damage condition.-material analysis: mar performed and state that, delamination, burnishing, scratching and third-body indentations are present on the insert.The event was confirmed by mar report.These are common damage modes of uhmwpe.Damage was observed on the femoral bushings and bumper insert consistent with contact against a hard object.Significant wear was observed on the bumper insert.Damage was observed on the axle and tibial rotating component, consistent with in-service use.Damage on the tibial rotating component likely occurred from contact with the femoral component.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of the product history records could not be performed as lot code are unknown.Complaint history review: a complaint history review could not be performed as lot code are unknown.Conclusions: it was reported that the patient was revised due to wear of the poly component.The event was confirmed by mar report.The investigation concluded that damage was observed on the femoral bushings and bumper insert consistent with contact against a hard object.Significant wear was observed on the bumper insert.Damage on the tibial rotating component likely occurred from contact with the femoral component.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.

• 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
• MDR Report Key: 8627587
• Report Number: 0002249697-2019-02022
• Device Sequence Number: 2256565
• Product Code: KRO
• UDI-Device Identifier: 07613327048841
• UDI-Public: 07613327048841
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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 Catalogue Number: 64952105
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 25 YR