MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number TIBIAL INSERT MB SZ 1 RT 8MM

Device Problem Fracture (1260)

Patient Problem Joint Laxity (4526)

Event Date 04/18/2023

Event Type  Injury  

Event Description

It was reported that a 75 yo female patient, who had multiple surgeries in 2017 on the right osg, who had an initial right vantage ankle implanted on (b)(6) 2020, underwent a revision procedure on (b)(6) 2023, approximately 3 years post the initial procedure.The patient was revised due to an inlay fracture and talus loosening on the right.The patient did not indicate a recognizable reason or a previous trauma that caused the event.The patient was revised to an exactech 10 mm inlay and a flat cut talus.There was no breakage of device or surgical delays.The patient was last known to be in stable condition following the event.X-rays and device photos were provided.No device returns anticipated.The implants will remain in the hospital for biomolecular research and control.No further information.

Manufacturer Narrative

Concomitants: 5184279 350-02-01e - taluskappe 1, re, 5226181 350-32-01 - tibiaplateau mobil 1, re.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

H3: the revision reported was likely due to the combination of patient-related conditions, more specifically hindfoot misalignment, and malrotation of the talar component, which may have allowed for incongruent loading and unexpected stresses on the implants, and led to ultimate tibial insert fracture and talar component loosening.However, this cannot be confirmed as the devices were not returned for evaluation.

• Brand Name: LOGIC
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16888351
• MDR Text Key: 314761200
• Report Number: 1038671-2023-00928
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TIBIAL INSERT MB SZ 1 RT 8MM
• Device Catalogue Number: 350-42-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2017
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female