MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE STEM TIBIAL MID SIZE 16MM RIGHT AND LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 200010902

Device Problems Device Difficult to Setup or Prepare (1487); Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.H3 other text : remains implanted.

Event Description

During an inbone total ankle replacement procedure, the 18mm base stem failed to thread into the other implants due to imperfections in its threads.Despite this setback, the surgery was successful as a backup 18mm base was used instead.

Event Description

During an inbone total ankle replacement procedure, the 18mm base stem failed to thread into the other implants due to imperfections in its threads.Despite this setback, the surgery was successful as a backup 18mm base was used instead.

Manufacturer Narrative

Correction: g1 reporting contact this device is concomitant and did not contribute to the reported event.¿ therefore, this complaint is closed without further investigation.¿ if any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: INBONE STEM TIBIAL MID SIZE 16MM RIGHT AND LEFT
• 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: 18411255
• MDR Text Key: 331625231
• Report Number: 3010667733-2023-00814
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420123862
• UDI-Public: 00840420123862
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051023
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 200010902
• Device Lot Number: 1753715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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