MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 3 RT 10MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	TIBIAL INSERT FB SZ 3 RT 10MM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case: (b)(6).As reported via legal documentation, this patient, a 62 year old male, is verified right ankle on (b)(6) 2018 and a right ankle revision on (b)(6) 2022, approximately 3 years and 11 months after their initial surgery.Postoperative diagnosis: painful right total ankle replacement, periprosthetic cyst underneath the talus.Inspection of the polyethylene demonstrated no evidence of fracture or delamination.The tibia and talar components were inspected and were stable.Patient was transferred to the recovery room in stable condition.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.Serial#: (b)(4), category#: 350-22-43 - tibial insert fb sz 3 rt 10mm, serial number: (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k152217.Concomitants: serial#: (b)(4), category#: 350-02-03 - talar implant sz 3 rt, serial#: (b)(4), category#: 350-10-04 - ankle sz 4 locking clip, serial#:(b)(4), category#: 350-12-04 - tibial plate fb sz 4 rt.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: serial#: (b)(4), category#: 350-02-03 - talar implant sz 3 rt, serial#: (b)(4), category#: 350-10-04 - ankle sz 4 locking clip, serial#: (b)(4), category#: 350-12-04 - tibial plate fb sz 4 rt.
Additional Manufacturer Narrative
H6, investigation-based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the patient pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.

• Brand Name: TIBIAL INSERT FB SZ 3 RT 10MM
• 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 ; 3523782617
• MDR Report Key: 16736571
• Report Number: 1038671-2023-00678
• Device Sequence Number: 15130904
• Product Code: HSN
• UDI-Device Identifier: 10885862293275
• UDI-Public: 10885862293275
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Model Number: TIBIAL INSERT FB SZ 3 RT 10MM
• Device Catalogue Number: 350-22-43
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0024-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male