MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; LINEAR, LATERAL, REDUCED NECK, SZ 11 W/P2 COATING

Catalog Number	425-99-011
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Joint Laxity (4526)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to patient sustained a fall which caused a periprosthetic fracture of the femur which required a revision surgery.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2022-00863; 425-99-014, s809 - trauma, revision surgery if additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: DJO SURGICAL
• Common Device Name: LINEAR, LATERAL, REDUCED NECK, SZ 11 W/P2 COATING
• 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: 21554679
• Report Number: 1644408-2025-00304
• Device Sequence Number: 8180175
• Product Code: LPH
• UDI-Device Identifier: 00888912078979
• UDI-Public: 00888912078979
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/07/2024

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: 425-99-011
• Device Lot Number: 576G1212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 411-00-153 LOT: 922B1056; 411-00-350 LOT: 931B2020
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male