MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR; SLIDING CORE, UHMPWE,7MM

Catalog Number	400-141F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to poor range of motion.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
There were (b)(4) similar complaints identified for star poly swaps with no indication of poly damage.Similar complaints identified do not aid in the investigation for this complaint as the lot numbers remain unknown for the similar complaints.Dhr review was not conducted due to the part and lot numbers remaining unknown.It is unknown if the doctor followed the surgical technique with the limited information available regarding the original implantation.The poly was not returned to the (b)(6) site, so visual and dimensional inspection did not occur.Simulated use testing did not occur.Due to the limited information regarding the reason for removal, the root cause shall remain as unknown.

• Brand Name: STAR
• Common Device Name: SLIDING CORE, UHMPWE,7MM
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19717059
• Report Number: 1644408-2024-01038
• Device Sequence Number: 18175317
• Product Code: NTG
• UDI-Device Identifier: 00886385026930
• UDI-Public: 00886385026930
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 400-141F
• Device Lot Number: 1311202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/11/2024
• 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; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male