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

Catalog Number UNK_WWA

Device Problems Malposition of Device (2616); Osseointegration Problem (3003); Migration (4003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/01/2023

Event Type  Injury  

Event Description

It was reported that the patient may need to undergo a revision surgery due to tibial component loosening and varus malalignment.

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.H3 other text : device remains implanted in patient.

Manufacturer Narrative

Correction h6 device code, result code, conclusion code.The reported event could be confirmed, based on available medical records and assessment of health care professionals.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.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed: after reviewing hcp opinion and surgeon¿s feedback we can conclude that the tibial component is loosened and migrated.Talar component not used as intended by user.Varus malposition was observed in talar component hence, loosening and migration of talar component could not be confirmed.Based on investigation, the root cause was attributed to a patient issue.The failure is detected by the migration of tibial components.While varus deformity in talar component.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that the patient may need to undergo a revision surgery due to tibial component loosening and varus malalignment.

• Brand Name: UNKNOWN TAR TIBIA COMPONENT
• 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: 18346073
• MDR Text Key: 330807789
• Report Number: 3010667733-2023-00786
• 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: 02/06/2024

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: 11/23/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 02/06/2024
• 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