MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INVISION SZ 2 LP PEGGED TALAR PLATE RT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 6000502R

Device Problems Osseointegration Problem (3003); Migration (4003)

Patient Problems Ossification (1428); Deformity/ Disfigurement (2360); Inadequate Osseointegration (2646)

Event Date 12/15/2023

Event Type  Injury  

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery because the talar implant subsided on the posterior lateral side leading the heel to fall into valgus.The patient also has some heterotopic ossification that needs to be removed.

Manufacturer Narrative

The reported event could be confirmed since images of ct scans were provided and shows subsidence of the talar component.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿there is no clear radiolucence or cysts visible.However, the ct supports the reported statement by the hcp, that there is a dorsolateral subsidence.That can be seen when scrolling through the ap-view.There is the condensed bone below the component and thus some subsidence/migration visible.¿ based on investigation, the root cause was attributed to a patient related issue.As reported by the surgeon, some underlying hindfoot valgus might have contributed to the problem.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device remains implanted in patient.

• Brand Name: INVISION SZ 2 LP PEGGED TALAR PLATE RT
• 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: 18813217
• MDR Text Key: 336615717
• Report Number: 3010667733-2024-00130
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153008
• 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: 02/29/2024

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: 6000502R
• Device Lot Number: 1698364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2024
• 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: Female
• Patient Weight: 70 KG