MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM ANKLE TIBIAL BASE SIZE 3; PROSTHESIS, ANKLE, SEMI-CONSTRAINED

Catalog Number 00450004300

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial ankle arthroplasty approximately four (4) months ago.Subsequently, it was noted in the patient's 12-week follow up that the tibial component has subsided.The surgeon is considering revision with a pmi device to implant a custom poly, but the patient is currently using a brace in the meantime.No revision procedure has been reported to date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: item# 00450001300; lot# 65829342.Item# 00450005304; lot# 65840746.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is unable to be confirmed.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.

Event Description

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

• Brand Name: TM ANKLE TIBIAL BASE SIZE 3
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18836957
• MDR Text Key: 336892833
• Report Number: 0001822565-2024-00695
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889024269651
• UDI-Public: (01)00889024269651(17)330522(10)65901353
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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 Catalogue Number: 00450004300
• Device Lot Number: 65901353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• 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
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Required Intervention
• Patient Sex: Male