MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS DIST FEM COMP SML R 65MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6495-2-020
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Post Operative Wound Infection (2446); Inadequate Osseointegration (2646)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: mrh tib rot comp xs-xl;64812100;166534.Mrhk bumper insert - neutral;64812130;ljm741.Mrhk tibial sleeve;64812140;ljr153.Mrhk tib ins 10mm xs/s s1/s2;64813210;ljm856.Mrs fem stem w/o body 13x127mm; 64853113;192496e.Gmrs small femoral bushing; 64952105;ljl233.Gmrs small femoral bushing; 64952105;ljn365.Gmrs small axle;64952115;ctd39632.Kmax stem extnr(s,m,l,xl),80mm;64768260;lcm1313.Mrh tibial b/plt keel sml 1; 64813110;h627b.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
It was reported that the patient's right knee was revised due to infection and loosening of the distal femur.A distal femur, 13x127 stem, bushings, bumper, axle, 10mm insert, rotating platform, and sleeve were revised.Rep provided the primary usage sheet and confirmed that no further information will be released.

• Brand Name: GMRS DIST FEM COMP SML R 65MM
• 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: 10556436
• Report Number: 0002249697-2020-01936
• Device Sequence Number: 14123982
• Product Code: KRO
• UDI-Device Identifier: 07613327048759
• UDI-Public: 07613327048759
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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: 09/30/2024
• Device Model Number: 6495-2-020
• Device Catalogue Number: 64952020
• Device Lot Number: HRB7R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/18/2020
• 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: 60 YR
• Patient Weight: 65