MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM FINN MOD PROX FMRL RT 7CM; PROSTHESIS, KNEE

Catalog Number	150457
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right total hip arthroplasty.Subsequently, the patient fell due to an unknown reason resulting in a fracture of the proximal body implant.The patient underwent a revision surgery and the proximal body was revised.All other components were retained.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 110010267 - g7 osseoti multihole 58mm g - (b)(6), 00625006560 - bone screw self-tapping 6.5 mm dia.60 mm length - (b)(6), 00625006525 - bone screw self-tapping 6.5 mm dia.25 mm length - (b)(6), 00625006550 - bone screw self-tapping 6.5 mm dia.50 mm length - (b)(6), 30203607 - liner constrained neutral 36 mm i.D.Size g for use with g7 acetabular system only - (b)(6), 11-107017 - freedom constr hd 36mm t1 -3mm - (b)(6), (b)(6) - unknown cement - 351ba983ke, unknown - unknown large claw - unknown.H6 : mechanical (g04) - head.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2.Upon receiving additional information of the reported event, it was determined to be not reportable as this device did not fracture and was not revised.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 available at the time of this report.

• Brand Name: ORTHOPEDIC SALVAGE SYSTEM FINN MOD PROX FMRL RT 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 ; 5745260384
• MDR Report Key: 22371458
• Report Number: 0001825034-2025-01923
• Device Sequence Number: 12785147
• Product Code: KWA
• UDI-Device Identifier: 00880304239784
• UDI-Public: (01)00880304239784(17)340224(10)65918228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043547
• 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: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: 150457
• Device Lot Number: 65918228
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White