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

Catalog Number 814131112

Device Problem Fracture (1260)

Patient Problem Non-union Bone Fracture (2369)

Event Date 03/30/2019

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 287339338
• Report Number: 0001825034-2022-00623
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00887868036958
• UDI-Public: (01)00887868036958(17)250930(10)393120
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention