MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TALDOME SZ1 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33680021

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 09/13/2022

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

Event Description

It was reported that the patient was revised and during revision it was noted that the pegs were broken off of the adaptis talar dome and the dome itself was loose from the talus.Dome and pegs were explanted (dome easily, pegs were all fused) and a new size 1 flat cut adaptis talar dome was implanted.

Manufacturer Narrative

The complaint could be confirmed, since the returned information for evaluation matches the alleged failure.Medical profession reviewed the received information and noted: apparently the adaptis talar component did not show osteointegration with the bone, except for the pegs.From the moment the undersurface is loose, and the pegs are not, then all joint forces acting on the talar component will be transmitted to the surface-peg-junction.These pegs are not designed to withstand these kinds of forces and will eventually break.Since we do not have information on the implantation (talar surface preparation, initial fit of the implant, bone quality, and other patient related factors that may influence osteointegration), a definitive root cause analysis can not be made (yet).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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient was revised and during revision it was noted that the pegs were broken off of the adaptis talar dome and the dome itself was loose from the talus.Dome and pegs were explanted (dome easily, pegs were all fused) and a new size 1 flat cut adaptis talar dome was implanted.

• Brand Name: INFINITY ADAPTIS TALDOME SZ1 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: 15563111
• MDR Text Key: 301356310
• Report Number: 3010667733-2022-00337
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797101516
• UDI-Public: 00889797101516
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33680021
• Device Catalogue Number: 33680021
• Device Lot Number: 1688187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• 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 Age: 61 YR
• Patient Sex: Female