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

Catalog Number	64952115
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding damage involving a gmrs axle reported.The event was confirmed by mar review.Product evaluation and results: visual inspection: burnishing was observed on the axle (figures 18 and 19) consistent with in-service use.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: 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 device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: a review indicated that there were no similar events for the reported lot.Conclusions: it was reported that the patient was revised due to wear of the component.The event was confirmed by mar review.Investigation concluded that 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.
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 is available.

• Brand Name: GMRS SMALL AXLE
• 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: 8939163
• Report Number: 0002249697-2019-02990
• Device Sequence Number: 2610244
• Product Code: KRO
• UDI-Device Identifier: 07613327048773
• UDI-Public: 07613327048773
• 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
• Report Date (Section B): 08/28/2019

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 Expiration Date: 05/31/2016
• Device Catalogue Number: 64952115
• Device Lot Number: CTD903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/28/2019
• 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