MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SIZE 4 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33650004

Device Problem Malposition of Device (2616)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 06/05/2023

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.

Event Description

It was reported that the patient presented for total ankle arthroplasty surgery using infinity implants.The surgery was done step by step according to the surgical technique.Before implantation, x-rays were taken to confirm the trials are in place according to recommendation.After implantation, the tibial tray is found to be distracted posteriorly.The surgeon removed the insert and tapped the tibia tray into position, and x-ray taken to confirm.The physician used a new insert, and implanted it.The same issue happened.Surgeon decide to close up.

Manufacturer Narrative

The reported event could be confirmed since x-ray images were provided and shows malposition of the tibial tray.Upon further investigation of the x-ray images by healthcare professionals the following was observed: ¿in the preoperative x-ray we can identify a tibial defect arthropathy with an anteriorly pronounced defect.The joint was already subluxated preoperatively and the posterior end of the joint line was far more distal than the anterior one.The whole alignment of the capsule changed according to this defect and altered anatomy of the joint.Therefore, it is possible, that the balance in the joint was severely disturbed, the capsule adapted to this situation, but as the operation with a joint replacement needs a realignment of these structures the dislocating factors remain.Hopefully, with the use and the adaptation of the soft tissues around the ankle joint, the problem will resolve, but it could just as well be going in the other direction and the malalignment and disbalance of the joint might further increase.¿ based on investigation, the root cause was attributed to a patient related issue.The failure was caused by a tibial defect arthropathy.As stated by a medical professional, ¿the joint was already subluxated preoperatively and the posterior end of the joint line was far more distal than the anterior one.The whole alignment of the capsule changed according to this defect and altered the anatomy of the joint.¿ a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient presented for total ankle arthroplasty surgery using infinity implants.The surgery was done step by step according to the surgical technique.Before implantation, x-rays were taken to confirm the trials are in place according to recommendation.After implantation, the tibial tray is found to be distracted posteriorly.The surgeon removed the insert and tapped the tibia tray into position, and x-ray taken to confirm.The physician used a new insert, and implanted it.The same issue happened.Surgeon decide to close up.

• Brand Name: INFINITY TIBIAL TRAY SIZE 4 TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17231966
• MDR Text Key: 318172116
• Report Number: 3010667733-2023-00351
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122513
• UDI-Public: 00840420122513
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K140749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 33650004
• Device Catalogue Number: 33650004
• Device Lot Number: 1732596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 85 KG