MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL PLATE 12 HOLE LEFT; PLATE, FIXATION, BONE

Catalog Number	814131112
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No product was returned; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not be determined.If any further information 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
It was reported that a patient underwent internal fixation of left distal femur fracture as well as proximal tibia fracture approximately 5 years ago with long length lateral plate and screw fixation device.Subsequently, patient felt a snap in leg about 3 years later and underwent open reduction internal fixation with repair of nonunion with graft.A new multi hole plate like the one that broke was inserted as well as all screw were reinserted at the exact same positions.Attempts have been made and there is no further information at this time.

• Brand Name: FEMORAL PLATE 12 HOLE LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13792223
• Report Number: 0001825034-2022-00623
• Device Sequence Number: 13868308
• Product Code: HRS
• UDI-Device Identifier: 00887868036958
• UDI-Public: (01)00887868036958(17)250930(10)393120
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K111663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 814131112
• Device Lot Number: 393120
• 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: 03/15/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2015
• 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: Unknown