MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ3LNG INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33680013

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Upon an x-ray it was noticed that the patient has a broken posterior peg on infinity adaptis tray.No further information is available yet.

Manufacturer Narrative

The reported event could be confirmed, since review of provided radiographic imaging does find the central posterior peg is fractured.Medical affairs was consulted on the details of the case.According to their review, "there is some radiolucence which could imply a loosening of the implant.That could be the underlying cause of the breakage.However, there seem to be no clear signs (pain/inability to walk) for a loosening." 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.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.

Event Description

Upon an x-ray it was noticed that the patient has a broken posterior peg on infinity adaptis tray.No further information is available yet.

• Brand Name: INFINITY ADAPTIS TIB SZ3LNG 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: 16448938
• MDR Text Key: 310373088
• Report Number: 3010667733-2023-00090
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797069687
• UDI-Public: 00889797069687
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181557
• 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: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33680013
• Device Catalogue Number: 33680013
• Device Lot Number: 1701193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• 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