MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PROXIMAL FEM COMP STD; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6495-1-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left total femur was revised.As reported: "pt.Presented with symptoms of an acute infection, lab-work and imaging determined the patient had an acute infection of the left-thigh.Surgeon performed an i&d of the patient¿s thigh and hip and determined it¿d be best to extend the incision down to the knee to ensure proper i&d of the patient¿s gmrs total-femur construct.Surgeon replaced all components listed on the original surgery-sheet except for the all-poly tibial component.It was considered well fixed and left in-situ.No complaints filed against the implants themselves.".
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: uhr bipolar 26x52mm; cat# uh1-52-26; lot#lw35y1 gmrs dist fem comp std l 65mm; cat#64952030; lot#lel6p mrhk femoral bushing; cat#64812110; lot#lkh493 26mm +4 lfit v40 head; cat# 6260-9-226; lot#84509506 mrhk femoral bushing; cat#64812110; lot#lkn210 medium krh all poly tibia 16mm; cat#64852216; lot#rth0112 mrhk bumper insert - neutral; cat#64812130; lot#lkb218 mrh axle; cat#64812120; lot#ctd62955 gmrs extension piece 220; cat#64956220; lot#h779a gmrs connection piece 90mm lft; cat#64956009; lot#ctd27776a gmrs extension piece 60mm; cat#64956060; lot#n2b3l mrh xs/s/m long xover; cat#64812103; lot#172782d.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned to the manufacturer.

• Brand Name: PROXIMAL FEM COMP STD
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14780547
• Report Number: 0002249697-2022-00894
• Device Sequence Number: 14936541
• Product Code: KRO
• UDI-Device Identifier: 07613327048704
• UDI-Public: 07613327048704
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2022

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: 6495-1-001
• Device Catalogue Number: 64951001
• Device Lot Number: NBB2N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male