MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL PLATE FB SZ 2 LT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-11-02
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitants: (b)(6) 350-10-02 - ankle sz 2 locking clip.(b)(6) 350-21-12 - tibial insert fb sz 2 lt 7mm.(b)(6) 350-03-02 - flat cut talus sz 2 l.(b)(6) 351-90-22 - 2.5" pin pouch.(b)(6) 351-90-24 - talar trial screw pouch.(b)(6) 351-90-21 - 3.5" pin pouch.(b)(6) 351-90-21 - 3.5" pin pouch.(b)(6) 351-90-20 - tubercle pin pouch.
Event or Problem Description
As reported, approximately 2.5 years post op initial left ankle replacement, this 56 y/o female patient was revised due the locking clip disassociated from tibial tray.Clip broke in situ.Surgeon swapped out clip & poly.Patient was last known to be in stable condition following the event.No images or x-rays available.

• Brand Name: TIBIAL PLATE FB SZ 2 LT
• Common Device Name: 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22500178
• Report Number: 1038671-2025-02497
• Device Sequence Number: 7001028
• Product Code: HSN
• UDI-Device Identifier: 10885862276148
• UDI-Public: 10885862276148
• Combination Product (Y/N): N
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2030
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 350-11-02
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 07/14/2025
• Date Device Manufactured: 12/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female