MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL PLATE FB SZ 3 RT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-12-03
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993); Implant subsidence (4078)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Discomfort (2330)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 350-22-22 - tibial insert fb sz 2 rt 8mm: 4748658.350-02-02 - talar implant sz 2 rt: 5231652.350-10-03 - ankle sz 3 locking clip: 5184595.(h3) pending evaluation.
Event or Problem Description
As reported by the exactech vantage total ankle study, the 33-year-old female patient had a right taa on (b)(6) 2018.On (b)(6) 2022, the patient presented with pain stating she noticed some discomfort during the previous wintertime.She stated her ankle is doing well with minimum pain and asymptomatic most days.On (b)(6) 2023, dr.(b)(6) ordered ct scan because she had complaints laterally and her x-rays showed some growth of the cyst in that area.On (b)(6) 2023, dr.(b)(6) stated that the subject described her pain as aching and burning, more intense with activity.The symptoms are aggravated by standing, walking, and weight bearing.Dr.(b)(6) elected to proceed with revision.The outcome of this event is considered resolved by action of revision on (b)(6) 2023.The case report form indicates that this event is definitely not related to the device and possibly related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1, b2, b3, b5, g1, h6 - health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings and investigation conclusions 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 right total ankle arthroplasty.Subsequently, the patient experienced pain, discomfort, cysts, tibial loosening and tibial subsidence.As a result, the patient underwent a right ankle revision approximately 5 years and 2 months after initial implantation.No further patient impact reported.No further information available.
Additional Manufacturer Narrative
His follow-up report is being submitted to relay additional information.The following sections were updated: h6, h11.H11: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was performed and identified that one tibial plate was rejected during qc inspection upon receipt from the supplier due to an ¿unknown part defect doesn't fit tibial plate used for comparator check.¿ the rejected unit was removed from the lot.The remaining components were accepted with conformance to the device requirements.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, was likely the result of tibial loosening and subsidence.Additional contributing factors may include the reported bone cysts and pain.However, this cannot be confirmed as the devices were not returned for evaluation and images and radiographs were not provided.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 3 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18941304
• Report Number: 1038671-2024-00589
• Device Sequence Number: 8381179
• Product Code: HSN
• UDI-Device Identifier: 10885862276193
• UDI-Public: 10885862276193
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

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: 350-12-03
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 01/22/2026; 02/18/2026
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 02/10/2026; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2018
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Race: White