MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY EVERLAST SZ 2+ 6MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33683206

Device Problems Material Fragmentation (1261); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 09/14/2023

Event Type  Injury  

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient underwent a revision surgery due to suspected infection.Upon testing it was noted that there was no infection but there was polyethylene debris.The patient received a cement spacer.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient underwent a revision surgery due to suspected infection.Upon testing it was noted that there was no infection but there was polyethylene debris.The patient received a cement spacer.

• Brand Name: INFINITY EVERLAST SZ 2+ 6MM 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: 17983989
• MDR Text Key: 326239112
• Report Number: 3010667733-2023-00621
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797074476
• UDI-Public: 00889797074476
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 33683206
• Device Lot Number: 1740918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• 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 Age: 66 YR
• Patient Sex: Male