BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 32/F

    MDR report key: 11027612 · Received December 17, 2020

    Report

    Report Number
    3005180920-2020-00902
    Event Type
    Injury
    Date Received
    December 17, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 17, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811951
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 DECEMBER 2020: LOT 1909324: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2019. EXPIRATION DATE: 2024-11-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: CUP: MPACT 01.32.156SH ACETABULAR SHELL Ø56 NO-HOLE (K132879) LOT. 2000215. BATCH REVIEW PERFORMED ON 27 NOVEMBER 2020: LOT 2000215: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2020. EXPIRATION DATE: 2025-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: VISUAL INSPECTION PERFORMED ON 16TH DECEMBER 2020. FROM THE RECEIVED PARTS, IT WAS NOT POSSIBLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT, BUT FROM THE SURFACES A POSSIBLE THIRD BODY PRESENCE HAS NOT TO BE EXCLUDED. CLINICA EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FEW WEEKS AFTER PRIMARY HYBRID THA THE PATIENT FEELS PAIN AT THE ABDOMEN AND CAN NOT BEAR WEIGHT. THE CUP IS REVISED, OSTEOLYSIS FOUND CRANIALLY TO THE IMPLANT AND A CEMENTED CUP PUT IN PLACE. GIVEN THE VERY LIMITED TIME IN VIVO, THE OSTEOLYSIS COULD NOT BE ORIGINATED BY THE IMPLANT. A LOW-GRADE INFECTION COULD BE AN EXPLANATION, BUT IT IS NOT MENTIONED IN THE REPORT. IF THE CAUSE FOR THE REMOVAL WAS POOR QUALITY BONE, CERTAINLY THE IMPLANT DID NOT PLAY A ROLE IN THIS ADVERSE EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD PAIN AND COULD NOT STAND ON THE LEG - THROUGH RADIOLOGICAL EXAMINATION, THE SURGEON SAW SOME OSTEOLYSIS ON THE CUP. HE DECIDED TO REMOVE IT AND TO IMPLANT A NEW ONE, 3 MONTHS AFTER PRIMARY SURGERY. SINCE THE BONE WAS NOT GOOD ENOUGH, WE HAD TO IMPLANT A CEMENTED ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490493 LINER: MPACT FLAT PE HC LINER 32/F ACETABULAR PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3248HCT 1909324 07630030811951

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention