BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT 01.32.158DH ACETABULAR SHELL Ø58 TWO-HOLES

    MDR report key: 18991056 · Received March 28, 2024

    Report

    Report Number
    3005180920-2024-00149
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810893
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 MARCH 2024. LOT 1900184: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2019. EXPIRATION DATE: 2024-04-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: LINER: MPACT 01.32.3648HCAT HOODED PE HC LINER Ø36/F (K132879) LOT 176974: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MARCH-2018. EXPIRATION DATE: 2023-02-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT 1903857: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JUL-2019. EXPIRATION DATE: 2024-07-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.32.6520 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20 (K103721) LOT 1904926: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2019. EXPIRATION DATE: 2024-06-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANALYSIS PERFORMED BY R&D PROJECT MANAGER. FROM THE RECEIVED IMAGES NO PARTICULAR SIGNS WERE NOTICED: THE COMPONENTS, IN PARTICULAR THE POLYETHYLENE LINER, WERE SLIGHTLY DAMAGED FOR THE REMOVAL. FROM THE RECEIVED IMAGES AND INFORMATION, WE CANNOT DETERMINE THE ROOT CAUSE OF THE EVENT, BUT THE LEG LENGTH DISCREPANCY WAS PROBABLY RELATED TO THE POSITIONING OF THE IMPLANTS. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIR DIRECTOR A REVISION OF THE ACETABULAR COMPONENTS WAS PERFORMED 4 YEARS AND 3 MONTHS AFTER THE PRIMARY THA. ACCORDING TO REPORT, THE REASON OF THE REVISION WAS LEG LENGTH DISCREPANCY (LLD). FROM THE AVAILABLE X-RAYS THE LLD CAN BE CONFIRMED BY COMPARING THE TWO SIDES, AS WELL AS AN INCREASED LATERAL OFFSET: THIS MAY HAVE CAUSED FUNCTIONAL DISCOMFORT TO THE PATIENT. THERE ARE NO SIGNS OF LOOSENING OR INFECTION ON EITHER THE ACETABULAR OR FEMORAL SIDE. THERE IS NO REASON TO SUSPECT A DEFECTIVE OR MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    AT 4 YEARS AND 3 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO LEG LENGTH DISCREPANCY. THERE WAS <1MM LLD, BUT THE PATIENT WAS UNHAPPY. THEREFORE, THE SURGEON DECIDED TO REVISE THE CUP TO CHANGE THE OFFSET AND LEG LENGTH MARGINALLY. CUP, LINER AND FEMORAL HEAD COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR'S COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028696 CUP: MPACT 01.32.158DH ACETABULAR SHELL Ø58 TWO-HOLES HIP ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 1900184 07630030810893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention