MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; FLARED RIM SHELL, HIP, P2 COATED W/O SCREWHOLES, 56MM

Catalog Number	430-96-056
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Cup shifted and dislocated.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2024-01834; 430-97-056, 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: FLARED RIM SHELL, HIP, P2 COATED W/O SCREWHOLES, 56MM
• 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
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 20841426
• Report Number: 1644408-2024-01838
• Device Sequence Number: 7942123
• Product Code: LPH
• UDI-Device Identifier: 00888912083706
• UDI-Public: 00888912083706
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K974095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/05/2024

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
• Device Expiration Date: 01/05/2023
• Device Catalogue Number: 430-96-056
• Device Lot Number: 979G1023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2017
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2017
• 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: 010-55-025 LOT 006A1097; 010-55-030 LOT 007A1061; 010-55-040 LOT 010A1137; 400-05-004 LOT 887B1049; 935-40-256 LOT 825F1014
• Patient Age: 69 YR
• Patient Sex: Female