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
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem 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".

• Brand Name: SLIDING CORE, UHMPWE,6M (STERILE PACKAGED)
• Common Device Name: 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
• Report Number: 3007420745-2023-00006
• Device Sequence Number: 19639786
• Product Code: NTG
• UDI-Device Identifier: 00886385026923
• UDI-Public: 00886385026923
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 400140F
• Device Lot Number: 1542132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown