MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ4LNG INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33680014

Device Problems Break (1069); Fracture (1260); Osseointegration Problem (3003)

Patient Problems Ossification (1428); Implant Pain (4561)

Event Date 07/17/2023

Event Type  Injury  

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.

Event Description

It was reported that the patient was implanted with an infinity with adaptis total ankle on (b)(6) 2022.The patient recently complained of pain.Upon review of imaging, the physician noticed abnormal bone growth around the ankle joint.During surgery to remove this bone growth, it was noticed that at least two if not all three tibial pegs were broken.The implant still felt solid so it was not removed.Patient was closed up and may need to undergo a revision surgery.

Event Description

It was reported that the patient was implanted with an infinity with adaptis total ankle on (b)(6) 2022.The patient recently complained of pain.Upon review of imaging, the physician noticed abnormal bone growth around the ankle joint.During surgery to remove this bone growth, it was noticed that at least two if not all three tibial pegs were broken.The implant still felt solid so it was not removed.Patient was closed up and may need to undergo a revision surgery.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.

• Brand Name: INFINITY ADAPTIS TIB SZ4LNG 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: 17542243
• MDR Text Key: 321132113
• Report Number: 3010667733-2023-00437
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797069694
• UDI-Public: 00889797069694
• 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: 10/22/2023

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: 33680014
• Device Lot Number: 1706317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male