MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_WWA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Date 06/28/2022

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient 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.

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision due to the patient's health and poor bone.

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision due to the patient's health and poor bone.

Manufacturer Narrative

Correction: h6 results and conclusion: the reported event could be confirmed with the help of medical documents provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿improper selection, placement, positioning, and fixation of the prosthetic components may result in unusual stress conditions and a subsequent reduction in service life of the prosthetic component.Periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone.¿ formal medical opinion was sought from an experienced independent medical expert as below.¿the ct-scan shows subsidence of the talar component with one of the pegs into the subtalar joint and the calcaneus.There are cystic changes in the remnants of the talus.All in all, the talar component is likely to be loose.The tibial component shows some radiolucency around the central post of the inbone implant, part of this is however metal artifact.There is some subsidence, without definitive signs of tibial component loosening.The pe-insert looks intact, please note that a detailed assessment is not possible due to its radiolucent nature.The most likely root cause seems patient-related to the assumed poor quality of the bone.The implant as such looks intact.¿ based on investigation, the root cause was primarily attributed to a patient factors related issue i.E.Poor quality of the bone.The medical opinion also states that ¿the talar component is subsided and likely to be loose with some cystic changes in the remnants of the talus.There is some subsidence of tibial component, without definitive signs of loosening.The pe-insert looks intact.The implant as such looks intact.¿ if device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INBONE¿ TOTAL ANKLE SYSTEM
• 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: 15083822
• MDR Text Key: 296378874
• Report Number: 3010667733-2022-00257
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/06/2022

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 12/06/2022
• 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): Hospitalization; Required Intervention