MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 2 RT 6MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number TIBIAL INSERT FB SZ 2 RT 6MM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 03/16/2022

Event Type  Injury  

Event Description

As reported, the patient had an initial ankle replacement on (b)(6) 2018.The patient presented with medial symptoms, mechanical in nature, but related to the superficial peroneal nerve.Radiographs show heterotopic ossification of medial gutter, causing impingement.The patient was revised on (b)(6) 2022, and the tibial insert and locking clip were replaced.This event report was received through clinical data collection activities.

Manufacturer Narrative

Pending investigation.Medical products: 350-02-02 - talar implant sz 2 rt 5148428, 350-10-01 - ankle sz 1 locking clip 5188250, 350-12-01 - tibial plate fb sz 1 rt 5238976, 351-91-03 - recipsawblade 8x50x1mm 239091.

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 issues.The cause of surgical revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.H7: z-0024-2022.

• Brand Name: TIBIAL INSERT FB SZ 2 RT 6MM
• Type of Device: 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: 15419013
• MDR Text Key: 299872499
• Report Number: 1038671-2022-01111
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862276346
• UDI-Public: 10885862276346
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

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
• Device Operator: Health Professional
• Device Model Number: TIBIAL INSERT FB SZ 2 RT 6MM
• Device Catalogue Number: 350-22-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White