MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLATCUT TALAR DOME SZ 3 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33680033

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2022

Event Type  malfunction  

Event Description

It was reported that the patient presented 3-6 months post surgery.X-rays showed a broken anterior peg on the talus.The patient is not in pain or nor suffering ill effects from the broken peg.There are no immediate plans to remove the implant.

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided on a supplemental report.Device remains implanted in patient.

Manufacturer Narrative

Correction h6 clinical code.The reported event could be confirmed, since the x-ray images provided matches the alleged failure mode.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.A medical professional reviewed the received information and noted the following: "the lateral x-ray shows the talar component with the broken anterior peg.The other peg has a clear radiolucent zone around it.There are no signs of complete osteointegration of the talar component, the same is the case for the posterior part of the tibial component.The ap image the talar component shows a fracture of the lateral anterior peg, and it seems that the medial anterior peg is somewhat bent at its tip.Furthermore, there is a radiolucent area around the medial anterior peg, as where the lateral anterior peg is seated in more sclerotic bone.There¿s no osteointegration of the undersurface of the talar component.All in all, the image suggests lack of osteointegration, putting too much stress on the pegs, whereas one peg has given way and it will not surprise me if the anterior medial peg will do also, unless the bone surrounding it weakens before that.As a clinician i would consider the possibility of a low-grade infection.If osteointegration of the whole component would take place soon, then i would not have great concerns.If osteointegration does not take place, further loosening is to be expected, broken peg or not.At this moment the broken peg most likely represents the lack of osteointegration.Since the broken peg was impacted in more dense bone, it gave away first." the current instructions for use were reviewed and states: "the patient must be advised of the limitations of the reconstruction and the need for protection of the prosthesis from full weight bearing until adequate fixation and healing have occurred.Excessive activity and trauma affecting the joint replacement have been implicated with failure of the reconstruction by loosening, fracture and/or wear of the prosthetic components." based on investigation, the root cause was attributed to a patient factor related issue.The failure was caused by the lack of osseointegration and the exertion of excessive stress on the pegs.As per medical opinion, "the image suggests lack of osteointegration, putting too much stress on the pegs, whereas one peg has given way and it will not surprise me if the anterior medial peg will do also, unless the bone surrounding it weakens before that." 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 the patient presented 3-6 months post surgery.X-rays showed a broken anterior peg on the talus.The patient is not in pain or nor suffering ill effects from the broken peg.There are no immediate plans to remove the implant.

• Brand Name: FLATCUT TALAR DOME SZ 3 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: 14684128
• MDR Text Key: 294143284
• Report Number: 3010667733-2022-00207
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797073073
• UDI-Public: 00889797073073
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33680033
• Device Catalogue Number: 33680033
• Device Lot Number: 1708825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2021
• 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 Age: 77 YR
• Patient Sex: Male