MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah MRHK TIB INS 10MM M/L M2/L2; prosthesis, knee, femorotibial, constrained, cemented, metal/polymer

Catalog Number	64813310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: it was reported that after implantation of a distal femoral construct including custom implants, patient has developed an infection.Surgeon's plan is to remove all implants except the restoration modular stem (used in the distal femur).For the custom gmrs restoration modular adapter and custom locking bolt, surgeon's plan is to remove the devices, wash them in betadine, and re-implant them.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
The following devices were also listed in this report: mod con dist stem 25 x 155 mm; cat # 6276-7-025; lot # cax094447c.Mrh tib rot comp xs-xl; cat # 64812100; lot # 220057a.Joint replacement_product; cat # c-mm100759-00; lot # aa5ra7.Joint replacement_product; cat # c-mm100759-01; lot # r223ah.Gmrs dist fem comp std l 65mm; cat # 64952030; lot # yba3d.Gmrs extension piece 30mm; cat # 64956030; lot # h2rdu.Mrh axle; cat # 64812120; lot # ctd125785.D-m 2.0mm beaded cable set vit; cat # 6704-0-520; lot # 29084951.Mrh tibial baseplate; cat # unk_lim; lot # unknown.Mrh stem (tibial); cat # unk_lim; lot # unknown.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 M/L 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; +353()61498200
• MDR Report Key: 25147072
• Report Number: 0002249697-2026-00393
• Device Sequence Number: 9324426
• Product Code: KRO
• UDI-Device Identifier: 07613327043822
• UDI-Public: 07613327043822
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 64813310
• Device Lot Number: LMT887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2026
• Supplement Date Received by Manufacturer: 08/30/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 204 LB