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 Problem Insufficient Information (4580)

Event Date 08/29/2022

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient. a review of the device history is not possible because the lot number was not communicated.If additional information becomes 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.

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

The reported event could be confirmed with the help of medical documents provided for investigation.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Formal medical opinion was sought from an experienced independent medical expert for the available information and he opined that- ¿the ct-scans shows a little subsidence of the tibial component without loss of bony fixation.The talar component shows the same.There is bone formation around the ankle as a part of progressive degeneration of the joints of the hindfoot.Without clinical information is not possible to assess the root cause for this revision.The device looks intact, so far patient-related factors are the most likely reason for revision.¿ based on the available information and medical expert opinion, the root cause is patient related factor if device is returned or any further information is provided, the investigation report 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: 15480484
• MDR Text Key: 300578721
• Report Number: 3010667733-2022-00317
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

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?: Yes
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 12/08/2022
• 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