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

Model Number	6495-2-030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection involving a gmrs femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.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.There have been no other similar events for the sterile lot referenced.Conclusions: it was reported that the knee was revised due to infection.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: cat# 64812140; mrhk tibial sleeve; lot# lkl783, cat# 64956030; gmrs extension piece 30mm; lot# lnr7l, cat# 64812120;mrh axle; lot# ctd50606, cat# 64812100; mrh tib rot comp xs-xl; lot# 172892, cat# 64812110; mrhk femoral bushing; lot# lkm027, cat# 64952105; gmrs small femoral bushing; lot# lkl459, cat# 64813213; mrhk tib ins 13mm xs/s s1/s2; lot# lkp932, cat# 64812130; mrhk bumper insert - neutral; lot# lkc714, cat# 64813111 mrh tibial b/plt keel sml 2; lot# lrb3a, cat# 64853113; mrs fem stem w/o body 13x127mm; lot# 228535f, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that the patient's left distal femur replacement was revised due to infection.All devices except the tibial baseplate and a stem were revised.Aside from attached primary and revision, usage sheets, rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: GMRS DIST FEM COMP STD L 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: 11918461
• Report Number: 0002249697-2021-00960
• Device Sequence Number: 3179904
• Product Code: KRO
• UDI-Device Identifier: 07613327049824
• UDI-Public: 07613327049824
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 12/31/2025
• Device Model Number: 6495-2-030
• Device Catalogue Number: 64952030
• Device Lot Number: LEP4E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/02/2021
• 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