BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-OP ACETABULAR SYSTEM

    MDR report key: 337180 · Received June 12, 2001

    Report

    Report Number
    337180
    Event Type
    Malfunction
    Date Received
    June 12, 2001
    Date of Event
    August 8, 2000
    Report Date
    June 12, 2001
    Manufacturer
    SULZER MEDICA
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SULZER MEDICA VOLUNTARILY RECALLED SPECIFIC LOTS OF INTER-OP ACETABULAR SHELLS FOLLOWING REVIEW OF THE MANUFACTURING PROCESS. THIS PT RECEIVED ONE OF THE RECALLED ACETABULAR SHELLS. PT HAD RELACEMENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26867 INTER-OP ACETABULAR SYSTEM HEMISPHERICAL POROUS SHELL WITH SEALED SCREWHOLES LPH SULZER MEDICA * 1414481
    26868 INTER-OP ACETABULAR SYSTEM HOODED INSERT SIZE 28MM I.D. X 51MM O.D. LPH SULZER MEDICA * 1384873
    26869 APR II-T HIP SYSTEM POROUS DISTAL GRIT BLAST FEMORAL STEM STANDARD BODY 35MM NEC LPH SULZER MEDICA * 1399041
    26870 TOTAL HEAD, NEUTRAL NECK HEAD, NEUTRAL NECK USE WITH 12/14 TAPER STEMS ONLY LPH SULZER MEDICA * 1430790

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other