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

Model Number	350-12-02
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646); Swelling/ Edema (4577)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 58 year old female patient had an initial total ankle arthroplasty on (b)(6) 2022.The patient presented with a failed tibial component and had immediate pain, swelling, and cyst formation.The patient was revised on (b)(6) 2023.The vantage total ankle implants were removed and an antibiotic spacer was placed.Cultures were taken.No infection.Custom cage implant being made for an ankle fusion.The reported event is not related to the breakage of a device and did not lead to surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical product(s): 6886384, 350-04-02 - flat cut talus sz 2 r; a168490, 350-10-02 - ankle sz 2 locking clip; 5719693, 350-22-02 - tibial insert fb sz 2 rt 6mm; 6858393, 351-90-20 - tubercle pin pouch; 6871658, 351-90-21 - 3.5" pin pouch; 6871663, 351-90-21 - 3.5" pin pouch; a181050, 351-90-22 - 2.5" pin pouch.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e, f, g.The revision reported was likely due to tibial loosening secondary to patient¿s reported poor bone quality, failure to gain adequate bone in-growth within the central cage, and potential contributions from non-cemented usage.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TIBIAL PLATE FB SZ 2 RT
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16655283
• Report Number: 1038671-2023-00558
• Device Sequence Number: 5924641
• Product Code: HSN
• UDI-Device Identifier: 10885862276186
• UDI-Public: 10885862276186
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 350-12-02
• Device Catalogue Number: 350-12-02
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 09/20/2023; 07/22/2025
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 10/04/2023; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Race: Black Or African American