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

Catalog Number UNK_WWA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Cyst(s) (1800); Insufficient Information (4580)

Event Date 05/31/2022

Event Type  Injury  

Event Description

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

Manufacturer Narrative

Based on the available information the device will not be returned 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.Device remains implanted in patient.

Event Description

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

Manufacturer Narrative

Correction - h6 (clinical code, results code and conclusion code) the reported event could be confirmed, since review of imaging provided indicates loosening and the potential need for a revision if symptomatic.Medical affairs was consulted regarding this case.Per their review of the provided imaging, "the images show subsidence of the tibial component with the formation of bony cysts.The same holds true for the talar component to a lesser extent.If this subsidence/loosening is symptomatic, i can image it being a reason for revision.So far, the implant shows no irregularities." additional information received from the initial reporter indicate the reason for revision to be ankle arthritis.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by loosening caused by ankle arthritis.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 was not possible because the catalog number and lot number were not communicated.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.

• Brand Name: UNKNOWN_WRIGHT MEDICAL-ARLINGTON_PRODUCT
• 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: 14823504
• MDR Text Key: 294802170
• Report Number: 3010667733-2022-00219
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2022
• 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
• Date Manufacturer Received: 08/30/2022
• 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