MAUDE Adverse Event Report: Zimmer Biomet, Inc. Orthopedic Salvage System Segmental Elliptical Femur Right 7cm; Prosthesis, Knee

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address a femoral periprosthetic fracture after a fall approximately five (5) months post-operatively.No additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - orthopedic salvage system cemented im stem 17mm x 90mm catalog #: 150364 lot #: 65790717, orthopedic salvage system modular tibial baseplate 67mm catalog #: 150421 lot #: 66702470, orthopedic salvage system tibial sleeve augment small catalog #: 161045 lot #: 67087297, orthopedic salvage system cemented im stem 12mm x 90mm catalog #: 150361 lot #: 65752927, orthopedic salvage system reinforced yoke catalog #: 150493 lot #: 67606806, orthopedic salvage system axle catalog #: 150480 lot #: 67606790, orthopedic salvage system poly lock pin catalog #: 150478 lot #: 67538553, orthopedic salvage system poly femoral bushings 2pk catalog #: 150477 lot #: 66521551, orthopedic salvage system poly tibial bushing catalog #: 150476 lot #: 67526913, orthopedic salvage system tibial poly bearing 16mm catalog #: 150412 lot #: 67549312, trabecular metal diaphyseal cone 30 small right catalog #: 00545001731 lot #: 66481205 g2: foreign - event occurred in australia h6 - component code - proposed code is mechanical (g04) - femur the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: Orthopedic Salvage System Segmental Elliptical Femur Right 7cm
• 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: 50410549
• Report Number: 0001825034-2026-02507
• Device Sequence Number: 9173167
• Product Code: JDI
• UDI-Device Identifier: 00880304238848
• UDI-Public: (01)00880304238848(17)350406(10)67131917
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 150356
• Device Lot Number: 67131917
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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 Sex: Unknown