MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TALAR; PROSTHESIS ANKLE

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(udi): n/a.Medical product: catalog #: unknown, tibial, lot # unknown.Catalog #: unknown, articular surface, lot # unknown.Chen j, akoh cc, somerson js, easley me, adams sb, deorio jk, nunley ja.Analysis of 408 total ankle arthroplasty adverse events reported to the us food and drug administration from 2015 to 2018.Foot ankle specialist (2020), doi:10.1177/1938640020919538.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02747, 0001822565-2020-02748.Location unknown.

Event Description

It was reported that there was one direct surgeon error causing an unknown adverse event related to user error.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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.

• Brand Name: UNKNOWN TALAR
• Type of Device: PROSTHESIS ANKLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10345294
• MDR Text Key: 201558500
• Report Number: 0001822565-2020-02739
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other