MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TALDOME SZ2 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33680022

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/08/2023

Event Type  Injury  

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient gets a stress fracture and implant loosening following stress fracture.The patient will be undergoing a revision procedure.

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.

Manufacturer Narrative

Correction - h6 (clinical signs code, health code, device code).Based on investigation findings of all the components involved by the internal healthcare professional it was concluded that the reported event was due to tibial tray implant subsidence/loosening due to poor bone quality and stress fracture.The root cause was attributed most likely due to patient related issue.This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient gets a stress fracture and implant loosening following stress fracture.The patient will be undergoing a revision procedure.

• Brand Name: INFINITY ADAPTIS TALDOME SZ2 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: 17264121
• MDR Text Key: 318448376
• Report Number: 3010667733-2023-00367
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797101523
• UDI-Public: 00889797101523
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172633
• 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: 10/06/2023

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 Model Number: 33680022
• Device Catalogue Number: 33680022
• Device Lot Number: 1710223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 10/06/2023
• 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