MAUDE Adverse Event Report: EXACTECH, INC. PRIM+ TIB-L-15MM-SZ4; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	03-PML-15-0004
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10: 03-cnb-cd-0001 - v3d corner drill - zh.351-10-34 - tibial bone removal scrw.351-91-04 - saw-10x75x1.19-stryker (b)(6).351-91-03 - recip sawblade 8x50x1mm (b)(6).351-50-21 - psi 3d plus tibia (b)(6).350-01-03 - talar implant sz 3 lt (b)(6).350-23-43 - vit e liner-l-sz 3-10mm (b)(6).03-cmb-lc-0004 - p/p+ locking clip - sz4 (b)(6).351-90-21 - 3.5" pin pouch (b)(6).351-90-21 - 3.5" pin pouch (b)(6).351-90-22 - 2.5" pin pouch (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial left total ankle arthroplasty.Subsequently, it was reported that the patient is experiencing liftoff of the tibial plate.Upon a follow-up appointment with the patient the surgeon reported "tibial implant is almost completed seated now.Great rom".No medical or surgical intervention was reported as a result of this event.No further information available.

• Brand Name: PRIM+ TIB-L-15MM-SZ4
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 23498988
• Report Number: 1038671-2025-03291
• Device Sequence Number: 18390751
• Product Code: HSN
• UDI-Device Identifier: 10885862623003
• UDI-Public: 10885862623003
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K230717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03-PML-15-0004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/07/2025
• Date Device Manufactured: 08/27/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown