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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient is considering a right knee arthroplasty revision to address femoral yoke implant fracture approximately fourteen (14) months post-operatively.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - orthopaedic salvage system poly tibial bushing catalog #: 150476 lot #: 66133305, orthopaedic salvage system rs tibial bearing 12mm catalog #: 161094 lot #: 65677455, orthopaedic salvage system poly lock pin catalog #: 150478 lot #: 66077510, orthopaedic salvage system axle catalog #: 161035 lot #: 65816766, unknown orthopaedic salvage system femoral component catalog #: ni lot #: ni.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient is considering a right knee arthroplasty revision to address femoral yoke implant fracture accompanied by pain, swelling and instability approximately fourteen (14) months post-operatively after a fall.Initial operative notes noted no intraoperative complications.Attempts have been made, however, no additional information is available.
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.Radiographic review of x-rays provided confirmed the implant had fractured.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ORTHOPAEDIC 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: 21263749
• Report Number: 0001825034-2025-00214
• Device Sequence Number: 9546067
• Product Code: KRO
• UDI-Device Identifier: 00880304240094
• UDI-Public: (01)00880304240094(17)330221(10)65676365
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2025

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: 65676365
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 02/04/2025; 05/22/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/25/2025; 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 104 KG