MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 1 LT 7MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 350-21-11

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 02/08/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.

Event Description

As reported via legal documentation a 54 y/o female patient had a left ankle replacement on (b)(6) 2019.Approximately 3 years and 2 months after the initial procedure the patient had a left ankle revision on (b)(6) 2023.Clinical exam and radiographs demonstrated failure of tibial component with subsidence posteriorly.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023.Diagnosis: failed left total ankle replacement.Capsule from the anterior aspect of the ankle was sent to pathology as well as microbiology.There were no complications.The patient was stable upon transfer to the pacu.

• Brand Name: TIBIAL INSERT FB SZ 1 LT 7MM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17083607
• MDR Text Key: 316751116
• Report Number: 1038671-2023-01280
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862276254
• UDI-Public: 10885862276254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2023

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 Model Number: 350-21-11
• Device Catalogue Number: 350-21-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/07/2023
• Date Device Manufactured: 12/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female