MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah MRHK TIB INS 13MM XS/S S1/S2; prosthesis, knee, femorotibial, constrained, cemented, metal/polymer

Catalog Number	64813213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient revised due to chronic infection.No other information available due to hospital policy." surgery performed 1 day after date of awareness.All components except a baseplate and stem(s) were removed.Left dfr.Revision, infection.
Additional Manufacturer Narrative
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.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.The following devices were also listed in this report: gmrs small femoral bushing; cat# 64952105; lot# lne117; qty : (b)(4).Mrhk bumper ins 3 degrees; cat# 64813233; lot# lmn053.Mrhk tibial sleeve; cat# 64812140; lot# lmx600.Mrh tib rot comp xs-xl; cat# 64812100; lot# 220030.Gmrs dist fem comp sml l 65mm; cat# 64952010; lot# tae7y.Gmrs extension piece 50mm; cat# 64950650; lot# h3lxu.Gmrs small axle; cat# 64952115; lot# ctd114548.Mrs cvd fem st w/o body 17x127; cat# 64853817; lot# 254830a.Mrh tibial b/plt keel sml 2; cat# 64813111; lot# ty69d.Dcon p-fit stem cocr 13mmx80mm; cat# 64786398; lot# epb9r.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: MRHK TIB INS 13MM XS/S S1/S2
• 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: deepan raju srinivasan ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50430781
• Report Number: 0002249697-2026-00756
• Device Sequence Number: 13354843
• Product Code: KRO
• UDI-Device Identifier: 07613327043792
• UDI-Public: 07613327043792
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: 64813213
• Device Lot Number: LLT568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2023
• 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: 77 YR
• Patient Sex: Male