MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TIB TRAY RT SZ 3 LNG; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 220222903

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Discomfort (2330); Inadequate Osseointegration (2646)

Event Date 10/10/2023

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 had post traumatic arthritis from a prior pilon fracture.The distal tibial bone was rather soft at the time of surgery- the talar component collapsed into some valgus.The patient had a tibial periprosthetic fracture that required surgery.The patient continues to have discomfort.The physician is planning to revise the patient with longer tibial stem for added stability.The physician plans to have a nail back up in case the bone is too soft and unable to revise.

Event Description

It was reported that the patient had post traumatic arthritis from a prior pilon fracture.The distal tibial bone was rather soft at the time of surgery- the talar component collapsed into some valgus.The patient had a tibial periprosthetic fracture that required surgery.The patient continues to have discomfort.The physician is planning to revise the patient with longer tibial stem for added stability.The physician plans to have a nail back up in case the bone is too soft and unable to revise.During a later conversation the physician reported that the implant components were not the cause of the failure, it was the patient's poor quality of bone.They plan on revising in the near future but the patient is currently having cardiac issues and has not been cleared by cardiology.

Manufacturer Narrative

Correction - h6 (device code).The reported event could be confirmed based on available medical record and medical expert assessment.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed all components are intact.The tibial component has subsided anteriorly and into a slight varus position.The ct-scan shows an overall poor bone quality (osteopenic appearance).No signs of loosening and/or chronic infection.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by ospenic bone of patient if device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INBONE TIB TRAY RT SZ 3 LNG
• 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: 18069708
• MDR Text Key: 327351539
• Report Number: 3010667733-2023-00667
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100886
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 220222903
• Device Lot Number: 1667288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2019
• 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: Female