MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERIARTICULAR DIS LAT FMRL LK PLT 14H LT; PLATE, FIXATION, BONE

Catalog Number	00235710214
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Periprosthetic fracture (4902)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: france h3: customer 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
It was reported that the patient underwent a left femoral osteosynthesis approximately five (5) months ago.Subsequently, the patient underwent a revision surgery approximately a month ago due to the implant fracturing.It is unknown at this time what caused the implant to fracture, the patient denies falling.Attempt has been made to obtain additional information.No additional information has been received at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a4; b4; b5; b7; d2; d6; d9; g1; g3; g6; h1; h2; h3; h6 the reported event was confirmed by review of x-rays.Ap and lateral views show a markedly comminuted distal femoral diaphyseal fracture with angulation and rotation of the components.There appears to be extension into the metaphysis.Subsequent images show changes of osteosynthesis with long lateral plate, several metaphyseal condylar screws and 5 femoral diaphyseal screws as well as multiple cerclage wires around the diaphysis and fracture site.Near anatomic alignment of the fracture is noted with partial fracture healing on visit 3 images.The final images show a new angulated fracture of the lateral plate between the metaphyseal condylar screws and the most distal cerclage wire near the distal aspect of the fracture margin.Visual examination of the returned product identified the plate shows signs of use with some scratching on the surface of the plate as well as some discoloration in the holes and possible thread damage.The plate has fractured about 1/4 of the way from one end of the plate.All pieces were returned.Fracture analysis noted the fracture surface exhibited smeared artifacts in some parts, likely due to contact damage, and suspected fatigue crack initiation near the threads.However, no fracture artifacts were identified clearly on the fracture surfaces.Therefore, failure mode could not be determined conclusively based on the optical images.Verified that the plate is visually conforming to the print.Overall length was not measured due to the fracture of the plate.Product information confirmed from etch.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.

• Brand Name: PERIARTICULAR DIS LAT FMRL LK PLT 14H LT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22213660
• Report Number: 0001822565-2025-01960
• Device Sequence Number: 8132189
• Product Code: HRS
• UDI-Device Identifier: 00889024056008
• UDI-Public: (01)00889024056008(10)65374711
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 11/24/2025

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: 00235710214
• Device Lot Number: 65374711
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 60 KG