MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKOWN FIBULAR PLATE; PROSTHESIS, TRAUMA

Catalog Number FIBULAR PLATE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 01/25/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, product is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Zimmer biomet will continue to monitor for trends.Associated mdr reports and products: 0001825034-2022-02845.Item# unkown syndesmotic screw; lot# unkown.0001825034-2022-02867.Item# unkown screw; lot# unkown.Other associated products: item# 00450004300; lot# 62529037, item# 00450001300; lot# 62442230, item# 00450005300; lot# 62267028.

Event Description

It was reported a patient had hardware removed eight (8) years post implantation due to pain and swelling.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: left ankle pain; synovitis, impingement, midfoot exostosis, hardware pain; left ankle arthrotomy, tibia/talus saucerization gutter debridement, saucerization 1st metatarsal and medial cuneiform, hardware removal lateral ankle.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot 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.Associated products and reports: 0001825034-2022-02867-1: item# unknown screw; lot# unknown.0001825034-2022-02845-1: item# unknown syndesmotic screw; lot# unknown.

Event Description

No further event information available at the time of this report.

Event Description

Upon receiving additional information of the reported event, it was determined to be not reportable as the device is a competitor product.The initial report should be voided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay corrected information.Upon receiving additional information of the reported event, it was determined to be not reportable as the device is a competitor product.The initial report should be voided.

• Brand Name: UNKOWN FIBULAR PLATE
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16064917
• MDR Text Key: 306322450
• Report Number: 0001825034-2022-02843
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: FIBULAR PLATE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/04/2023; 02/08/2023
• Supplement Dates FDA Received: 01/11/2023; 02/21/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 91 KG