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

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hyperextension (4523)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - orthopedic salvage system rs segmental femoral component left 8.5cm catalog #: 161124 lot #: 66097829, orthopedic salvage system polyethylene tibial bushing catalog #: 150476 lot #: 66873956, orthopedic salvage system rs tibial bearing 14mm catalog #: 161095 lot #: 65980346, orthopedic salvage system reinforced yoke catalog #: 150493 lot #: 66294444, orthopedic salvage system poly locking pin catalog #: 150478 lot #: 66573572, biomet series a standard 3-peg patella 31mm catalog #: 184764 lot #: 66339705.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.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address excessive hyperextension approximately one (1) year post-operatively.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h6, h10, h11.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address excessive hyperextension and instability approximately one (1) year post-operatively.During the revision, the femoral bushings and polyethylene tibial bearing were identified to have fractured.No additional patient consequences were reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10, h11.The following sections were corrected: h4.The device was evaluated, however, the reported event could not be confirmed.Visual evaluation of the returned device identified signs of use with marring present on the polished surface.Dimensional analysis of the product determined it was conforming to print specifications where measured.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: ORTHOPEDIC SALVAGE SYSTEM RS AXLE
• 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: 23555805
• Report Number: 0001825034-2025-03624
• Device Sequence Number: 9659970
• Product Code: KRO
• UDI-Device Identifier: 00880304250963
• UDI-Public: (01)00880304250963(17)340529(10)66654338
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K021260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 03/25/2026

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: 161035
• Device Lot Number: 66654338
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 11/21/2025; 03/24/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/09/2025; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female