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

Catalog Number UNK_WWA

Device Problem Loss of Osseointegration (2408)

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

Event Date 11/20/2023

Event Type  Injury  

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of both the tibial and talar components for reasons that are not available at the time of this report.

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 healthcare professionals the following was observed since the affected device was not returned and the lot number was not communicated, it is not possible to know according to which revision the product has been manufactured.Upon further investigation of the ct scans by healthcare professionals the following was observed "the tibial construct shows radiolucency, some cysts and there is a subsidence visible.Loosening and migration can be confirmed.No clear separation of pe from the tibial component, there is no breakage in talar dome construct some radiolucency.In comparison to the initial planning the implant looks subsided.It is not unlikely that the relatively short shaft of the inbone component has contributed to a loosening.If that is the case, the incident would at least partly be user/treatment related.However, the main cause for the failure is patient related poor bone substance." based on investigation, the root cause was attributed to a patient related issue.The failure was caused by poor bone substance of patient.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: UNKNOWN TIBIAL TOP STEM
• 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: 18781161
• MDR Text Key: 336288331
• Report Number: 3010667733-2024-00103
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• 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
• Date Manufacturer Received: 01/29/2024
• 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