MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN FIBIAL PLATE; PROSTHESIS, TRAUMA(?) HIP (? )

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Muscle/Tendon Damage (4532)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).Study: koo lee et al : a specialized fibular locking plate for lateral malleolar fractures.Information was received via a clinical study.Attempts were made to obtain additional information but were unsuccessful.Below are the results of the investigation: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Devices are used for treatment.Insufficient information provided.Unable to perform a compatibility check.Complaint history review cannot be performed without product identification.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.Reference report: 0001822565-2021-01397.

Event Description

A journal article was retrieved from the journal of foot & ankle surgery (2015) that reported a study from (b)(6) that looked at the outcomes and complications of a specialized fibular locking plate in the treatment of lateral malleolar fractures.The purpose of the study was to determine whether the use of a specialized locking plate would provide the same advantage for fixation of lateral malleolar fractures.The study reported one (b)(6)-year old female who had a left trimalleolar fracture developed an osteochondral lesion of the talus.The patient underwent arthroscopic debridement after device removal.

• Brand Name: UNKNOWN FIBIAL PLATE
• Type of Device: PROSTHESIS, TRAUMA(?) HIP (? )
• 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: 11912521
• MDR Text Key: 253694675
• Report Number: 0001822565-2021-01396
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ZPLP FIBULAR PLATE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR