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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address post-operative implant fracture and instability approximately twenty-one (21) months post-operatively.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - orthopedic salvage system rs tibial bearing 12mm catalog #: 161094 lot #: 151890.Orthopedic salvage system poly lock pin catalog #:150478 lot #: 747300.Orthopedic salvage system rs poly femoral bushings catalog #: 161034 lot #: 002820.Orthopedic salvage system nonmodular tibial plate long 71mm catalog #: 161043 lot #: 403920.Orthopedic salvage system rs 7cm ellip segmental femoral component left catalog #: 161010 lot #: 049500.Orthopedic salvage system rs axle catalog #: 161035 lot #: 683960.Orthopedic salvage system tibial bushing catalog #: ni lot #: 931960.Orthopedic salvage system bowed im stem catalog #: ni lot #: ni.G2 - report source - foreign: event occurred in spain.The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Visual examination of the returned yoke identified surface scratches and both flange tabs had fractured off the body of the implant.Dimensional analysis of the returned implant determined that the device was conforming to print specifications where measured.Further analysis determined that the fracture surface suggested the device possibly fractured due to fatigue.Radiographic review of x-rays taken prior to the revision demonstrated potential metallic loose bodies within the joint space and angulation at the hinge that suggested possible hardware fracture.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• 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: 20652377
• Report Number: 0001825034-2024-02649
• Device Sequence Number: 12843178
• Product Code: KRO
• UDI-Device Identifier: 00880304240094
• UDI-Public: (01)00880304240094(17)320819(10)163570
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K052685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 150493
• Device Lot Number: 163570
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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 Sex: Unknown