BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT 3D METAL 01.38.052DH ACETABULAR SHELL Ø52 TWO-HOLE

    MDR report key: 16435539 · Received February 24, 2023

    Report

    Report Number
    3005180920-2023-00104
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    January 25, 2023
    Report Date
    August 19, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812590
    PMA / PMN Number
    K171966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 FEBRUARY 2023: LOT 1903153:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2019. EXPIRATION DATE: 2024-05-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT 1909759: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2020. EXPIRATION DATE: 2025-03-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2000182: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2020. EXPIRATION DATE: 2025-05-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30 (K103721) LOT 2001168: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2020. EXPIRATION DATE: 2025-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING GROIN PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON BELIEVED THAT A LOOSE ACETABULAR IMPLANT WAS PRESENT. DURING THE REVISION SURGERY (AT ABOUT 2 YEARS AND 5 MONTHS FROM PRIMARY), HOWEVER, THE SURGEON NOTED THAT THE JOINT WAS STABLE AND THE CUP WAS DIFFICULT TO REMOVE. THE SURGEON DID OBSERVE THAT THERE WAS CIRCUMFERENTIAL BONY INGROWTH AS HE REMOVED THE CUP. THE SURGEON REVISED THE MEDACTA CUP, LINER, AND SCREWS WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO COMMENT FROM THE SURGEON ABOUT A POSSIBLE REASON OF PATIENT'S PAIN. THE SURGEON HAS NO REASON/THEORY ABOUT WHAT THE CAUSE OF THE PAIN WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934501 CUP: MPACT 3D METAL 01.38.052DH ACETABULAR SHELL Ø52 TWO-HOLE HIP ACETABULAR SHELL Ø52 TWO-HOLE LPH MEDACTA INTERNATIONAL SA 01.38.052DH 1903153 07630030812590

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention