MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR; SLIDJNG CORE, UHMPWE,8MM

Catalog Number	400-142F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - poly swap, unknown reason.
Additional Manufacturer Narrative
Poly swap, unknown reason.Due to the original poly lot numbers remaining unknown, simulated use testing cannot be conducted utilizing similar parts to simulate the event.Additionally, the poly component was implanted for over 10 years, so simulated use testing would not be able to accurately recreate the physiological changes that occurred during implantation.There were 50 similar complaints identified for star poly swaps with no reported damage beyond normal wear.Previous complaints were investigated and documented by stryker prior to february 2023 and do not aid in investigation for this complaint.Similar complaints identified after february 2023 had a root cause of unknown and do not aid in the investigation for this complaint.Ohr review was not conducted due to the complaint part not being returned and the lot number remaining unknown.It is unknown if the doctor followed the surgical technique with the limited information available.The poly was not returned, so visual and dimensional inspection did not occur.Simulated use testing did not occur as the poly was implanted for over 10 years and the lot number remains unknown.The condition of the poly was not reported.Based on the limited information, and the poly not being returned, the root cause shall remain as unknown.The following information remains unknown: date implanted, patient height, weight, activity level, noncompliance, and co-morbidities, inventory type, lot number, inventory status.Information not provided is not available to the reporter.Thus, good faith effort was achieved.The overall risk is high with a risk index of 3.Severity level of 4 (significant) is appropriate as there could be permanent functional impairment of body function and the failure may occur with or without warning.It is to be noted that no adverse events were reported resulting from the swapped poly.It was determined that 736 tibial polymer components (pn:4oo-14x) were sold during august 2022 and august 2023.With 51 reported events, the occurrence rate is (b)(4).Thus, an occurrence level of 5 (frequenuhigh) is appropriate.Per rf-str-ooo1 revision 2 risk benefit analysis for u23.2, "every endoprosthesis has a limited lifespan.With state-of-the-art techniques, there is no potential for further mitigation of the risks from a clinical point of view".Therefore, the risk shall remain appropriate.Though the root cause is unknown, it is not expected to be attributed to the supplier.

• Brand Name: STAR
• Common Device Name: SLIDJNG CORE, UHMPWE,8MM
• 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: 24671387
• Report Number: 1644408-2026-00620
• Device Sequence Number: 10204145
• Product Code: NTG
• UDI-Device Identifier: 00886385026947
• UDI-Public: 00886385026947
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 03/23/2026

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: 400-142F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 03/23/2026
• 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: Other
• Patient Age: 50 YR
• Patient Sex: Female