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

Catalog Number UNK_WWA

Device Problem Osseointegration Problem (3003)

Patient Problems Cyst(s) (1800); Inadequate Osseointegration (2646)

Event Date 01/02/2024

Event Type  Injury  

Manufacturer Narrative

The reported event could be confirmed, based on available ct scans and medical expert assessment 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.Upon further investigation of the ct scans by stryker's internal healthcare professionals the following was observed "tibial (construct): there is clear radiolucence visible, indicating loosening of the implant.Migration cannot be confirmed.Pe: the pe is not separated from the tibial construct, there is no indirect sign of loosening or migration.Talar (construct): the talar implant shows radiolucence, there is also some cysts visible.Clear loosening and migration/subsidence of the implant can be confirmed." based on investigation, the root cause was attributed to a patient related issue.The failure is detected by the radiolucence and cyst around tibial and talar component respectively.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device remains implanted in patient.

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to talar component subsidence.

• 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: 18965467
• MDR Text Key: 338429467
• Report Number: 3010667733-2024-00168
• 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
• 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?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/23/2024
• 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
• Patient Sex: Male