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

Catalog Number UNK_WWA

Device Problems Break (1069); Fracture (1260); Unstable (1667); Osseointegration Problem (3003); Migration (4003)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 06/20/2023

Event Type  Injury  

Event Description

It was reported that the patient may need to undergo a revision surgery due the tibial component loosening and the implant breaking through the pegs.The patient also has medial column instability.

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 : the device remains implanted in the patient.

Manufacturer Narrative

Please note corrections regarding b1, h6 (results & conclusion codes): the complaint was confirmed, since the information for evaluation matches the alleged failure.Upon further investigation of the ct scans by healthcare professionals the following was observed: the tibial component shows radiolucence and some cavities.Loosening and lateral subsidence (migration) can be confirmed.The fracture of the pegs described by the surgeon is visible in one plane.There is no information given, that infection is present, however, it cannot be assessed with the ct scan only.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 lot number was not communicated.Based on investigation, the root cause was attributed to a patient factors issue.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 revision surgery due the tibial component loosening and the implant breaking through the pegs.The patient also has medial column instability.

• Brand Name: UNKNOWN TIBIAL 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: 17329510
• MDR Text Key: 319139630
• Report Number: 3010667733-2023-00389
• 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: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 10/04/2023
• 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
• Patient Sex: Male