MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM ANKLE TIBIAL INSERT COMPONENT SIZE 4; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problems Unstable (1667); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of birth - unknown date, (b)(6).Report source foreign: the event occurred in (b)(6).This device is not distributed in the usa.However, this report is being submitted as zimmer biomet has a similar device in the united states cleared under 510k number k120906.Multiple mdr's were filed for this event.Please see associated report(s): 0001822565 -2018 -03816.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Patient underwent ankle arthroplasty revision to address progressive valgus malalignment and subsequent instability.No further information has been made available at this time.

Manufacturer Narrative

This follow up report is being submitted to relay additional information.Examination of the reported device(s) was not possible as it was not returned.Review of device history records did not identify any related manufacturing deviations or anomalies that would have contributed to the reported event.X-ray review confirms the arthrosis of the ankle joint and tibial loosening.The investigation can draw no further conclusions with the information made available.Root cause is unable to be determined.If any further information is identified 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 information available.

• Brand Name: TM ANKLE TIBIAL INSERT COMPONENT SIZE 4
• Type of Device: PROSTHESIS, EXTREMITY
• 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: 7769509
• MDR Text Key: 116642441
• Report Number: 0001822565-2018-03817
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PN/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,Followup
• Report Date: 11/30/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00830005400
• Device Lot Number: 62998292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2015
• 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
• Treatment: 00830001400 TALAR COMPONENT, LOT 62990950
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 66