MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ4 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33680004

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/07/2022

Event Type  Injury  

Event Description

It was reported that the tibial component central posterior peg has broken.There may be a reoperation needed due to the implant not fixating properly into the tibia.

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.

Manufacturer Narrative

Correction - b1, b5, h1, h6 (results code).The reported event could be confirmed since x-ray imaging provided did depict the broken peg as reported.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 was not possible because the lot number was not communicated.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

It was reported that the tibial component central posterior peg has broken.Indication for the patient's procedure was a standard follow up-end stage ankle arthritis.Patient had good bone quality.The surgeon plans not to revise and leave the implant in the patient as is.

• Brand Name: INFINITY ADAPTIS TIB SZ4 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: 15900850
• MDR Text Key: 304677172
• Report Number: 3010667733-2022-00417
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797069663
• UDI-Public: 00889797069663
• 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: 03/28/2023

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 Model Number: 33680004
• Device Catalogue Number: 33680004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 03/28/2023
• 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