MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE SLIDING CORE, UHMPWE,6M (STERILE PACKAGED); PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400140F

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 08/28/2023

Event Type  Injury  

Event Description

On 11/15/2023, regulatory compliance specialist with stryker, emailed envois regulatory with a manufacturer incident report (mir) from the european union medical devices vigilance system regarding a 400-140f, sliding core, uhmpwe, that had broken and "the patient required emergency surgery to replace it".

Manufacturer Narrative

On 11/15/2023, regulatory compliance specialist with stryker, emailed envois regulatory with a manufacturer incident report (mir) from the european union medical devices vigilance system regarding a 400-140f, sliding core, uhmpwe, that had broken and "the patient required emergency surgery to replace it".The mir stated that the 400-141f was implanted on (b)(6) /2019.The mir contains no details as to what caused the 400-141f to break.There are no details regarding patient information such as age, gender, dob, weight, height, or activity level.There are no details regarding the facility location or surgeon involved in either the implant of the 400-141f nor the revision surgery that followed.The status of the explanted 400-141f is unknown.

• Brand Name: SLIDING CORE, UHMPWE,6M (STERILE PACKAGED)
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston, TX 77007
• Manufacturer (Section G): TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston, TX 77007
• Manufacturer Contact: justin lovelace ; 727 north shepherd drive; suite 100; houston,, TX 77007
• MDR Report Key: 18302649
• MDR Text Key: 330228190
• Report Number: 3007420745-2023-00006
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: 00886385026923
• UDI-Public: 00886385026923
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 400140F
• Device Lot Number: 1542132
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2023
• 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): Required Intervention