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

Catalog Number UNKOWN SYNDESMOTIC SCREW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported a patient had screw removed six (6) months post implantation due to pain and swelling.

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 and products: 0001825034-2022-02843, item#: unknown fibular plate; lot#: unknown; 0001825034-2022-02867, item#: unknown screw; lot#: unknown.Other associated products: item#: 00450004300; lot#: 62529037; item#: 00450001300; lot#: 62442230; item#: 00450005300; lot#: 62267028.

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: 4-weeks post-op: left ankle infection, possible superficial cellulitis; 1 week of augmentin, resolved 6-week follow-up: no swelling, moderate pain; full weight bearing; good alignment and stability 2-moths post-op: left plantar fasciitis; stretching, pt, straps, cream; resolved 2014 5-months post-op: anterior ankle pain; scope, syndesmotic screw removal from fibular plate, no procedure was required to be performed on the ankle device at this time.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.0001825034-2022-02843-1, item# unknown fibular plate; lot# unknown.0001825034-2022-02867-1, item# unknown 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: 16064908
• MDR Text Key: 306323219
• Report Number: 0001825034-2022-02845
• 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: 03/03/2023

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: UNKOWN SYNDESMOTIC SCREW
• 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; 03/03/2023
• 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: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female