MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 10MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: revision of patient s.W.Distal femur gmrs originally put in on (b)(6) 2025 (original case oa 11897482) due to infection at (b)(6) hospital on (b)(6) 2026 to t2 nail cement spacer (stage 1).
Additional Manufacturer Narrative
The following devices were also listed in this report: mrs cvd fem st w/o body 11x127; cat # 64853811; lot # 502321e.Small howmedica bone plug 1pk; cat # 6215-5-001; lot # cppacgo3bd.Gmrs extension piece 100mm; cat # 64956100; lot # u27ud.Gmrs dist fem comp sml l 65mm; cat # 64952010; lot # rrs6c.Gmrs small axle; cat # 64952115; lot # ctd114541.Gmrs small femoral bushing; cat # 64952105; lot # lne103.Gmrs small femoral bushing; cat # 64952105; lot # lnl264.Gmrs extension piece 60mm; cat # 64956060; lot # y376u.Mrh tibial b/plt keel sml 1; cat # 64813110; lot # 26a6p.Kmax stem extnr(s,m,l,xl),80mm; cat # 64768260; lot # lcp0121.Mrhk bumper insert - neutral; cat # 64812130; lot # lna443.Mrh tib rot comp xs-xl; cat # 64812100; lot # 220149.Small howmedica bone plug 1pk; cat # 6215-5-001; lot # cppabmo8 be.Mrhk tibial sleeve; cat # 64812140; lot # lnc832.Simplex tobramycin 1 pk; cat # 61971001; lot # tjf061.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been similar event(s) for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: MRHK TIB INS 10MM 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 25511432
• Report Number: 0002249697-2026-00516
• Device Sequence Number: 10543925
• Product Code: KRO
• UDI-Device Identifier: 07613327043785
• UDI-Public: 07613327043785
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K223069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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: 64813210
• Device Lot Number: LND157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Female