MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN TAR IMPLANT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_WWA

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003); Migration (4003)

Patient Problems Cyst(s) (1800); Bone Fracture(s) (1870); Inadequate Osseointegration (2646); Insufficient Information (4580)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device remains implanted therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.

Event Description

It was reported that the patient may need to undergo a total ankle replacement revision surgery for reasons that are not available at this time.

Manufacturer Narrative

Corrections h6: device code, result code, conclusion code the reported event could be confirmed since images of ct scans were provided and shows loosening and migration of the tibial component.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿there is clear radiolucence and there are some cysts around the tibial component.Therefore, loosening can be confirmed.There seems to be a periprosthetic little fracture as well and that led to some subsidence of the implant.Therefore, migration can be confirmed as well.¿ based on investigation, the root cause was attributed to a patient related issue.The failure was most likely caused by a periprosthetic fracture which led to subsidence of the implant.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.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 may need to undergo a total ankle replacement revision surgery for reasons that are not available at this time.

• Brand Name: UNKNOWN TAR IMPLANT
• 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: 18681821
• MDR Text Key: 335072939
• Report Number: 3010667733-2024-00052
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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: Lay User/Patient
• Device Catalogue Number: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/22/2024
• 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): Other