MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE STAR ANKLE SYSTEM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Model Number	400-142F
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported on 06/01/2023, by independent sales representative, via text to the regional account coordinator, asking for the price of a star ankle poly that was used during a star poly exchange case at (b)(6) specialty hospital on (b)(6) 2023.In a follow up email with the regional account coordinator stated "the original poly broke causing the revision case." he stated the original implant was a 400-142f, sliding core, uhmpwe, 8mm, and was implanted in 2021.The original facility, surgeon, and patient information are unknown.The 400-142f was discarded by the facility.
Event or Problem Description
The initial polyethylene component experienced structural failure, leading to the need for a revision procedure.The original implant employed was a 400-142f, sliding core, ultra-high molecular weight polyethylene (uhmpwe) material, with a diameter of 8mm, and had been surgically placed in 2021.

• Brand Name: STAR ANKLE SYSTEM
• 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: 17218645
• Report Number: 3007420745-2023-00004
• Device Sequence Number: 17700302
• Product Code: NTG
• UDI-Device Identifier: 00886385026947
• UDI-Public: 00886385026947
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 06/28/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 400-142F
• Device Catalogue Number: 400-142F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/28/2023
• 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