MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TM ANKLE PRODUCTS; TRAUMA, PROSTHESIS

Device Problem Unintended Movement (3026)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Jie chen, md, mph, craig c.Akoh, md, rishin kadakia, md, jeremy s.Somerson, md, mark e.Easley, md, samuel b.Adams, md, james k.Deorio, md, and james a.Nunley, m.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported, in a journal article from foot & ankle specialists, that reported a us study of adverse events, that six incidents of gutter impingement had occurred.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 Description

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

• Brand Name: UNKNOWN TM ANKLE PRODUCTS
• Type of Device: TRAUMA, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10356155
• MDR Text Key: 201686887
• Report Number: 0001822565-2020-02735
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other