MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ5 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33680005

Device Problem Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 12/21/2023

Event Type  Injury  

Manufacturer Narrative

The reported event could be confirmed based on available medical record and medical expert assessment.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed ¿there is clear radiolucence visible in the provided x-ray from 12-23.Therefore loosening of the tibial component is highly likely, however, there is no clear evidence of migration.The preoperative mri scan shows bone bruise and alteration of the bone stock specifically in the area of the former talar fracture following the work accident in 2017.There was at least some bone damage/ e.G.Inflammation visible which may have contributed to a small extent to the loosening of the implant- it could be said here, that, despite these changes, the event is thus falling into the responsibility of the treating surgeon (in addition to the bone condition that favored implant failure(patient related)).Overall, however, the post-traumatic bone and joint damage that can be demonstrated throughout will have led to persistent pain, which had to be remedied by a surgical measure (joint replacement in this case).¿ based on the investigation, the root cause was attributed to the patient related issue.The failure was detected due to some radiolucency around the tibial component and poor bone quality and hence the loosening of the tibial component can be confirmed, but there is no clear evidence of migration.Overall, the post-traumatic bone and joint damage would have led to persistent pain which can be remedied by a joint replacement.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that the patient presented for a 1 year follow up.Upon review of the case the physician noticed that the posterior peg of the talar component is broken and is not fully seated upon implantation.The patient underwent a revision procedure.

• Brand Name: INFINITY ADAPTIS TIB SZ5 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: 18967289
• MDR Text Key: 338435888
• Report Number: 3010667733-2024-00169
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797069670
• UDI-Public: 00889797069670
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 33680005
• Device Lot Number: 1741975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 54 YR
• Patient Weight: 118 KG