MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR; SLIDING CORE, UHMPWE,9MM

Catalog Number	400-143F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Poly swap, unknown reason.There were 51 star revision complaints identified in the timeframe reviewed.Similar complaints did not aid in root cause determination as there is very limited information available.The new polyethylene component is pn 400-143f, sliding core, uhmpwe, 9mm, but the pn of the explanted component remains unknown.Due to the limited information available, the part and lot number could not be narrowed down and dhr review could not be completed.No information was provided related to the surgical technique, so adherence to the ifu is unknown.Simulated use not conducted for either returned device(s) nor with similar parts.The construct had been implanted for an unknown amount of time, so simulated use testing would not be able to accurately recreate the physiological changes that occurred during implantation.Multiple hazards are identified both during and after the initial procedure for which the effect is revision surgery, including 1.1 excessive handling / holding forces, 1.4 excessive immune response, 1.9 excessive instrument debris generated, 1.12 excessive packaging debris generated, 1.15 too high forces applied during bone preparation, 1.13 excessive heat generated, 9.1 missing devices, 23.1 insufficient wound healing, and 23.2 implant failure.Because the reason for the revision surgery is unknown, the risk with the highest severity and occurrence levels will be assessed.23.2 implant failure caused by multifactorial intrinsic reasons has a severity of 4 (significant) and a mitigated occurrence level of 3 (seldom/low), which corresponds to a risk index level of 2.Severity level of 4 (significant) is appropriate as there could be permanent impairment of body function and the failure may occur with or without warning.There were 714 star sliding cores (pns 99-0028-1x, 602-03-00x, 400-14x) sold between september 2023 and september 2024.Given that 51 reported star revisions occurred in that time, the occurrence rate is (b)(4).This would correspond to an occurrence level of 5 (frequent/high), which is for frequencies greater than 1%.The risk matrix does not adequately capture the occurrence level of risks associated with implant failure and shall be updated to better reflect this information.No information was provided regarding the cause of the revision surgery and the original surgery date.For this reason, the similar complaints could not aid in the investigation.It is unknown if the doctor followed the surgical technique during both the original and revision surgeries, so simulated use testing could not occur.The explanted poly was not returned to the houston site, so visual and dimensional inspection did not occur.The root cause shall therefore remain unknown.
Event or Problem Description
Revision surgery - poly swap, unknown reason.

• Brand Name: STAR
• Common Device Name: SLIDING CORE, UHMPWE,9MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 24933084
• Report Number: 1644408-2026-00857
• Device Sequence Number: 17481964
• Product Code: NTG
• UDI-Device Identifier: 00886385026954
• UDI-Public: 00886385026954
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 04/20/2026

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: 400-143F
• Device Lot Number: 2127032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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