MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 16MM MD/LG M2/L2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813316
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/04/2024
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: gmrs dist fem comp sml r 65mm; cat# 64952020; lot# jsl4c.Gmrs extension piece 30mm; cat# 64956030; lot# ljs7e.Mrs fem stem w/0 body 15x127mm; cat# 64853115; lot# 226391c.Gmrs small axle; cat# 64952115; lot# ctd48261.Gmrs small femoral bushing; cat# 64952105; lot# lke838.Mrhk tibial sleeve; cat# 64812140; lot# lkc371.Mrh tib rot comp xs-xl; cat# 64812100; lot# 172813.Mrh tibial b/plt keel med 2; cat# 64813112; lot# j2d4a.Triathlon cemented stem-15mm x 100mm; cat# 5560-s-215; lot# 0106767d.Duracon m-2 10mm full wedge; cat# 6630-6-525; lot# a439ra.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The following information was provided: the patient had an index right tka outside of cors scope.On (b)(6) 2020 patient underwent revision for pji, with all components exchanged, into a rotating hinge.The patient developed pji again and was revised on (b)(6) 2024, with an off-label use of components.All femoral and rotating hinge components were exchanged, except tibial components.

• Brand Name: MRHK TIB INS 16MM MD/LG M2/L2
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 23836342
• Report Number: 0002249697-2025-01495
• Device Sequence Number: 17401399
• Product Code: KRO
• UDI-Device Identifier: 07613327043853
• UDI-Public: 07613327043853
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K223069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: 09/30/2025
• Device Catalogue Number: 64813316
• Device Lot Number: LKE987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2020
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 76 KG