MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN INBONE SULCUS TALAR DOME; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_WWA

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Joint Laxity (4526); Insufficient Information (4580)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

This record is a consolidation of events summarized as part of literature review, when device and patient information is not available.This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged 1 patient that experienced instability which required revision surgery as mentioned in the registry could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The manufacturer became aware of (b)(6).The report provides information on the usage and outcomes of the inbone total ankle system.This report includes analysis of the clinical data that was collected on 219 patients, the cases in this study range from 28 july 2006 and 2 june 2021.This report was generated on june 3, 2021.During the review of the registry, it was not possible to establish a specific device details, patient information, and no additional device information will be made available.It was reported that 1 patient experienced instability which required revision surgery.

Manufacturer Narrative

Please note correction to h1: this is not a summary report.The number of events summarized field is blank as this mdr submission pertains to one patient.

Event Description

The manufacturer became aware of national registry released by the australian orthopaedic association national joint replacement registry.The report provides information on the usage and outcomes of the inbone total ankle system.This report includes analysis of the clinical data that was collected on 219 patients, the cases in this study range from 28 july 2006 and 2 june 2021.This report was generated on june 3, 2021.During the review of the registry, it was not possible to establish a specific device details, patient information, and no additional device information will be made available.It was reported that 1 patient experienced instability which required revision surgery.

• Brand Name: UNKNOWN INBONE SULCUS TALAR DOME
• 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; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13588085
• MDR Text Key: 290520503
• Report Number: 3010667733-2022-00104
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

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: 01/28/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 03/28/2024
• 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