MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLATCUT TALAR DOME SZ 2 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33680032

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 08/19/2022

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed. a review of the device history is not possible because the lot number was not communicated. should additional information become available, it will be provided on a supplemental report.Device disposition unknown.

Event Description

It was reported that a patient underwent a revision surgery to remove infinity adaptis tibial tray and talar dome.3 pegs of the tibial tray were broken and one of the talar dome pegs were broken.Cultures came back and confirmed the patient had an infection.

Manufacturer Narrative

Correction - h6 conclusion code the reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Medical affairs was consulted on the few details provided for this case.According to their review regarding the infection and tibial and talar pegs, "in the case of an infection the loss of osteointegration is likely to start from the joint side, therefore it could be that the load was transferred to the pegs completely and led to the breakage." there are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.Also, there are many sources of infection during and after surgical procedures.A review of the sterilization documents for the lots involved were found to be complete and within specifications.While it can be concluded the fractured pegs were a result of the infection inhibiting osseointegration, 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 infection.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

It was reported that a patient presented with pain and underwent a revision surgery to remove infinity adaptis tibial tray and talar dome.3 pegs of the tibial tray were broken and one of the talar dome pegs were broken.Cultures came back and confirmed the patient had an infection.The patient was put on vancomycin in the hospital.

• Brand Name: FLATCUT TALAR DOME SZ 2 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: 16452904
• MDR Text Key: 310346278
• Report Number: 3010667733-2023-00092
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191393
• 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: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33680032
• Device Catalogue Number: 33680032
• Device Lot Number: 1706915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• 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