MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 1 LT 6MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 350-21-01

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 10/14/2022

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10.Concomitants: 6192676, 350-03-01 - flat cut talus sz 1 l.5805048, 350-10-02 - ankle sz 2 locking clip.5810672, 350-11-02 - tibial plate fb sz 2 lt.5653779, 351-90-20 - tubercle pin pouch.6172437, 351-90-21 - 3.5" pin pouch.6130656, 351-90-22 - 2.5" pin pouch.371714, 351-91-03 - recip sawblade 8x50x1mm.339764, 351-91-04 - saw-10x75x1.19-stryker.

Event Description

As reported via legal documentation, a patient had left ankle replacement on (b)(6) 2019 due to end-stage arthritis, left ankle, and cystic formation, left talus.They underwent left ankle revision surgery on (b)(6) 2022, approximately 3 years 1 month post primary procedure.In revision op report, the surgeon noted that there was a significant amount of scar tissue formation at the anterior aspect of the ankle joint with significant invagination into the joint and medial and lateral ankle gutters.There was small bone growth over the anterior aspect of the tibial tray.There is significant amount of fibrotic scar tissue noted along the medial and lateral aspects of the ankle joint.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.

Manufacturer Narrative

H10.Additional information ¿ b5, d5, h6 medical device problem code.H3.Investigation results- the tibial insert fb sz 1 lt 6mm with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s 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.The patient has right ankle issues, all biomechanical issues can affect the stressors on the left ankle possibly to cause pain.As part of the pre-operative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.These devices are used for treatment not diagnosis.

Event Description

Preoperative diagnosis: 1: presence of artificial ankle implant 2: synovitis left ankle- 3: pain left ankle 4: complication of internal hardware left ankle 5: posttraumatic arthritis right foot/ the patient was revised to competitor's devices.Prophylactic fixation medial malleolus left ankle.The patient tolerated procedures and anesthesia well with vital signs stable and vascular status intact to the surgical limb.The patient was escorted to the recovery room in stable condition.There is no additional information available.

• Brand Name: TIBIAL INSERT FB SZ 1 LT 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 17663653
• MDR Text Key: 322476676
• Report Number: 1038671-2023-02121
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862276216
• UDI-Public: 10885862276216
• 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: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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 Catalogue Number: 350-21-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0024-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female