MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL LATERAL FEMORAL PLATE LEFT 10 HOLES 223 MM LENGTH; ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, NON-STERILE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Swelling/ Edema (4577)
Date of Event	09/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product/provided pictures identified the plate is broken at the screw hole as shown in the provided x-rays.The lot number 63170271 is etched on the broken plate.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fractured lateral plate device and osteopenia.The fractured plate occurs at the level of the comminuted fracture of the distal femoral diaphysis.A definitive root cause cannot be determined.The reported event is confirmed by mmi report and provided photos.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 is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).G2: china.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 a patient underwent a revision procedure approximately 5 months post implantation due to a broken femur plate.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: DISTAL LATERAL FEMORAL PLATE LEFT 10 HOLES 223 MM LENGTH
• Common Device Name: ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, NON-STERILE
• 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: 21197267
• Report Number: 0001822565-2025-00154
• Device Sequence Number: 8534522
• Product Code: HRS
• UDI-Device Identifier: 00889024055995
• UDI-Public: (01)00889024055995(10)63170271
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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 Model Number: N/A
• Device Catalogue Number: 00235710210
• Device Lot Number: 63170271
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2015
• 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: Unknown