MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY POLY SZ 4+ 7MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33655407

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/06/2023

Event Type  Injury  

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to pain and possible loosening/cystic changes.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.

Manufacturer Narrative

Upon additional information received it was noted that this component is not reportable.The pain and possible loosening/cystic changes have been attributed to the tibial and talar components and have been reported in mfr# 3010667733-2023-00097 and mfr# 3010667733-2023-00099.

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to pain and possible loosening/cystic changes.

• Brand Name: INFINITY POLY SZ 4+ 7MM TOTAL ANKLE SYSTEM
• 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: 17848198
• MDR Text Key: 324638267
• Report Number: 3010667733-2023-00574
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122827
• UDI-Public: 00840420122827
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100886
• 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: 01/02/2024

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: 33655407
• Device Lot Number: 1607692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 01/02/2024
• 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 Age: 71 YR
• Patient Sex: Male