MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE; PROSTHESIS, KNEE

Catalog Number	150493
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown oss diaphyseal segment: catalog#ni, lot#ni; unknown oss tibial poly bearing: catalog#ni, lot#ni; unknown oss poly bumper lock pin: catalog#ni, lot#ni; unknown oss poly tibial bushing: catalog#ni, lot#ni; unknown oss rs poly femoral bushings: catalog#ni, lot#ni; unknown oss rs axle: catalog#ni, lot#ni; unknown oss rs segmental femoral component: catalog#ni, lot#ni the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an orthopedic salvage procedure on an unknown date.Subsequently, on an unknown timeframe post-implantation, the patient underwent revision surgery due to component failure.Due diligence is in progress for this event; to date no additional information has been provided.
Event or Problem Description
It was reported that a patient underwent an orthopedic salvage procedure.Approximately four (4) years post-implantation, the patient underwent revision surgery due to fracture of the taper on the diaphyseal segment at the femoral insertion point as well as fracture of the wings on the tibial yoke.Affected components were replaced without reported complication.Due diligence is complete and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d1; d2; d4; d6a; d9; d10; g3; g4; h2; h4; h6; h10; h11.D10: medical product: oss 3cm ellip diaphyseal seg: catalog#150461, lot#556840; oss rs poly fem bushings set/2: catalog#161034, lot#354040; oss rs 7 cm mod seg fmrl-rt: catalog#161011, lot#588790; oss rs axle: catalog#161035, lot#514330; oss poly lock pin: catalog#150478, lot#483570; oss poly tibial bushing: catalog#150476, lot#949890; tibial central cone size fixed tibia: catalog#42545000508, lot#64815919; oss tibial poly bearing 20mm: catalog#150414, lot#171430; oss cemented im stem 15x300mm: catalog#150379, lot#121070; bead tip guide wire 3.0x98cm: catalog#27922, lot#468870; bead tip guide wire 3.0x98cm: catalog#27922, lot#698440.The product has been received for further evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h11.Visual inspection of returned yoke exhibits signs of use (scratches and marring) and both the tabs have fractured off.Further analysis of the fractured surface exhibits ratchet marks and faint beach marks artifacts suggesting that the device possibly fractured due to fatigue mode of failure.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a third-party healthcare professional which state that the femoral diaphyseal segment has fractured at its junction with the distal femoral component, and the distal femoral component is displaced laterally by nearly 1 shaft width.The reported event was confirmed by review of provided radiographs.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE
• 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 ; 5745260384
• MDR Report Key: 22512646
• Report Number: 0001825034-2025-02117
• Device Sequence Number: 15616343
• Product Code: JDI
• UDI-Device Identifier: 00880304240094
• UDI-Public: (01)00880304240094(17)310127(10)601850
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 150493
• Device Lot Number: 601850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 10/08/2025; 12/26/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 11/06/2025; 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 155 KG