MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLAT CUT TALAR DOME SZ 3 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33680033

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Limb Fracture (4518)

Event Date 01/11/2024

Event Type  Injury  

Manufacturer Narrative

The reported event that could be confirmed, based on available medical records and 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 shows some radiolucence and some cysts.It is subsidence anteriorly.Loosening and migration could be confirmed.Pe seems attached with components, no sign of breakage or separation.The talar component shows some radiolucence.Loosening is likely possible.There is no clear evidence of migration.Based on investigation, the root cause was attributed to a patient related issue.The patient falling and/or patient non-compliance has been indicated by treating surgeon in this event.The failure is detected by the radiolucence and subsidence of tibial components and radiolucency around talar component.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 of the tibial component.It was reported that the patient fell and fractured tibia and dislodged and migrated tibial component.Patient claims it was not due to a fall or noncompliance.After reviewing post-op x-rays and current x-rays, the physician believes patient did in fact fall or was noncompliant.

• Brand Name: FLAT CUT TALAR DOME SZ 3 INFINITY ADAPTIS
• 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: 18916530
• MDR Text Key: 337811306
• Report Number: 3010667733-2024-00158
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797073073
• UDI-Public: 00889797073073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191393
• 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: 03/15/2024

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: 33680033
• Device Lot Number: 1760829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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