MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ4LNG INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33680014

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Non-union Bone Fracture (2369); Inadequate Osseointegration (2646); Limb Fracture (4518); Implant Pain (4561)

Event Date 07/13/2023

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.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 underwent a primary procedure for total ankle replacement.During the procedure it was noted that the patient specific guide was mixed up with another patient's guide.Due to this the patient had a medial malleolar fracture.The patient elected to non-surgically and then it shifted and started to subside but he was still very happy with how his ankle felt and the pain relief.The physician reported that it had nothing to do with the implants, but rather the users technical errors.The patient will need to undergo a revision surgery.

Event Description

It was reported that the patient underwent a primary procedure for total ankle replacement.During the procedure it was noted that the patient specific guide was mixed up with another patient's guide.Due to this the patient had a medial malleolar fracture.The patient elected to non-surgically and then it shifted and started to subside but he was still very happy with how his ankle felt and the pain relief.The physician reported that it had nothing to do with the implants, but rather the users technical errors.The patient will need to undergo a revision surgery.

Manufacturer Narrative

The reported event could be confirmed since images of ct scans shows loosening of the tibial component and a non-union of a medial malleolar fracture.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿the ct scan shows a non-union of a medial malleolar fracture.The tibial component has migrated, ¿flipping¿ over backwards due to significant anterior subsidence/bone loss.The implant is definitively loose.There is bone adherence to the adaptis layer, yet this bone is loose from the tibial bone.No signs of loosening of the talar component.I conclude the primary root cause is a user-related issue, and possible secondary factors such as bone quality, are patient related.It is difficult to assess the influence of secondary factors in this case.¿ based on investigation, the root cause was attributed to a user related issue.Due to a mix-up in central sterilization, the wrong prophecy guides were used during the primary surgical procedure which resulted in a medial malleolar fracture with insertion of the tibial component.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.

• Brand Name: INFINITY ADAPTIS TIB SZ4LNG INFINITY ADAPTIS
• 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: 17497500
• MDR Text Key: 320764215
• Report Number: 3010667733-2023-00432
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797069694
• UDI-Public: 00889797069694
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

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 Catalogue Number: 33680014
• Device Lot Number: 1719296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• 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 Sex: Male