MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SUGICAL; EMPOWR 3D KNEETM, PRESS FIT FEMUR, 5L

Catalog Number	243-01-105
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery required due to patient fall and dislocation/fracture.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2024-00447; 243-02-110, 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 SUGICAL
• Common Device Name: EMPOWR 3D KNEETM, PRESS FIT FEMUR, 5L
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 20861104
• Report Number: 1644408-2024-01847
• Device Sequence Number: 11731503
• Product Code: MBH
• UDI-Device Identifier: 00190446231264
• UDI-Public: 00190446231264
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/05/2024

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: 243-01-105
• Device Lot Number: 274W1095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2023
• 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: 341-14-705 LOT 129T1086; 353-01-105 LOT 190W1067
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 82 KG