MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL LATERAL TIBIAL PLATE RIGHT 14 HOLES 189 MM LENGTH; PLATE, FIXATION

Model Number	2357-09-14
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign- (b)(6).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.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
It was reported that the patient underwent an initial tibial fracture surgery.Subsequently, the patient was revised approximately eight months post initial implantation due to plate fracture.No additional patient consequences were reported.
Event or Problem Description
It was reported that the patient underwent an initial tibial fracture surgery.Subsequently, the patient was revised approximately eight months post initial implantation due to plate fracture, radiolucency at the tibial screw indicating loosening, and tibial fracture nonunion.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, a3, b4, b5, b6, b7, e1, e2, e3, g3, g6, h1, h2, h3, h6, h10.Reported event was confirmed by review of medical records.Review of the available records identified that ap postoperative view showed plate and screw fixation of a distal tibial fracture with anatomic alignment and a proximal fibula fracture.Lucency was noted along an adjacent independent screw at the level of the plate fracture.Osseous alignment appeared maintained.The fracture appears ununited.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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.

• Brand Name: DISTAL LATERAL TIBIAL PLATE RIGHT 14 HOLES 189 MM LENGTH
• Common Device Name: PLATE, FIXATION
• 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: 13535287
• Report Number: 0001822565-2022-00422
• Device Sequence Number: 4039897
• Product Code: HRS
• UDI-Device Identifier: 00889024055797
• UDI-Public: (01)00889024055797(11)180417(10)63966611
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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 Model Number: 2357-09-14
• Device Catalogue Number: 00235700914
• Device Lot Number: 63966611
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• 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 Age: 69 YR
• Patient Sex: Female