MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; HEAD, FEMORAL, COCR 28/+3.5MM

Catalog Number	497-28-350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	02/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to dr.Did a hemi hip on.This patient fell on and dislocated the hip and the bipolar shell and 28mm head disassociated.Dr.Revised the hip with a longer neck which stabilized the hip.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2021-00742; 497-36-000, s809 - trauma, s803 - dislocation, 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: HEAD, FEMORAL, COCR 28/+3.5MM
• 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: 21440150
• Report Number: 1644408-2025-00226
• Device Sequence Number: 20004431
• Product Code: LPH
• UDI-Device Identifier: 00888912024044
• UDI-Public: 00888912024044
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K932481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/21/2025

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 Expiration Date: 09/05/2025
• Device Catalogue Number: 497-28-350
• Device Lot Number: 634C1231
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2019
• 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: 412-02-054 LOT: 002C1123
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male