BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL I ACETABULAR CUP

    MDR report key: 2013598 · Received March 10, 2011

    Report

    Report Number
    1825034-2011-00165
    Event Type
    Injury
    Date Received
    March 10, 2011
    Report Date
    February 11, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION BEING REPORTED WAS FOUND IN THE JOURNAL ARTICLE TITLED "CEMENTLESS FEMORAL FIXATION IN THE RHEUMATOID PATIENT UNDERGOING TOTAL HIP ARTHROPLASTY". J ARTHROPLASTY 2001;16(4):415-421 CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE REVISIONS MENTIONED IN THE JOURNAL ARTICLE. DATES OF EVENT - UNKNOWN. EXPIRATION DATES - UNKNOWN. DATES IMPLANTED - UNKNOWN. DATES EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY RH ROTHMAN, KS KEISU, F OROZCO, JD MCCALLUM, G BISSETT, WJ HOZACK AND PF SHARKEY. MANUFACTURE DATES - UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE REFERENCING A RETROSPECTIVE STUDY OF HIP PROCEDURES THAT TOOK PLACE BETWEEN (B)(6) 1986 AND (B)(6) 1992 UTILIZING UNIVERSAL I ACETABULAR CUPS. THE ARTICLE INDICATED THAT SEVEN ACETABULAR REVISIONS WERE PERFORMED FOR UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL I ACETABULAR CUP PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R