MAUDE Adverse Event Report: Zimmer Biomet, Inc. Orthopedic Salvage System RS Segmental Femoral Right 8.5cm; Prosthesis, Knee

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address femoral loosening approximately two (2) years post-operatively.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - orthopedic salvage system reinforced yoke catalog #: 150493 lot #: 66293962, orthopedic salvage system poly tibial bushing catalog #: 150476 lot #: 65783373, orthopedic salvage system rs poly femoral bushings 2 catalog #: 161034 lot #: 66198022, orthopedic salvage system poly locking pin catalog #: 150478 lot #: 66097309, orthopedic salvage system rs axle catalog #: 161035 lot #: 66326451, orthopedic salvage system tibial poly bearing 12mm catalog #: 150410 lot #: 66414358, orthopedic salvage system elliptical diaphyseal segment 3cm catalog #: 150461 lot #: 66182834, orthopedic salvage system cemented im stem 15mm x 225mm catalog #: 150375 lot #: 984140, persona tibial central cone size small catalog #: 42545000511 lot #: 64800269.H6 - component code - proposed code is mechanical (g04) - femur.The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: Orthopedic Salvage System RS Segmental Femoral Right 8.5cm
• Common Device Name: Prosthesis, Knee
• Manufacturer (Section D): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50119228
• Report Number: 0001825034-2026-02259
• Device Sequence Number: 13281327
• Product Code: KRO
• UDI-Device Identifier: 00880304554733
• UDI-Public: (01)00880304554733(17)320402(10)827900
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K051479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 161123
• Device Lot Number: 827900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: See H11 Narrative.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female