BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC MODULAR ACETABULAR SYSTEM (SPIDERCUP, RIMCUP, BATCUP)

    MDR report key: 7925130 · Received October 2, 2018

    Report

    Report Number
    0009610576-2018-00036
    Event Type
    Injury
    Date Received
    October 2, 2018
    Report Date
    October 2, 2018
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    PBI
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THERE IS A LACK OF INFORMATION, THE NATURE OF THE INCIDENCES GATHERED ON THIS COMPLAINT COMPLIES WITH CFR 21 - PART 803 MEDICAL DEVICE REPORTING SUBPART E¿MANUFACTURER REPORTING REQUIREMENTS 803.50. COMPLETE INFORMATION REGARDING THIS EVENT HAS NOT BEEN RECEIVED. THIS EVENT IS BEING NOTIFIED BASED ON THE STATEMENT ¿PRE-DISPOSITION TO REPORT RATHER THAN NOT TO REPORT IN CASE OF DOUBT¿ THIS PRODUCT IS MANUFACTURED BY BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K121874. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    DURING THE PERFORMANCE OF THE SCHEDULE PMS SURVEY HIP - MODULAR CUP SYSTEM# 19 REV.3, THE SURVEY PERFORMED BY DR (B)(6) OF THE (B)(6) REVEALS SOME ISSUES (POSTOPERATIVE COMPLICATIONS DUE TO DISLOCATION, DEEP INFECTION >3 MONTHS, SUPERFICIAL INFECTION AND PERI-PROSTHETIC FRACTURE; IMPLANT REVISION DUE TO SEPTIC LOOSENING AND RECURRENT DISLOCATION) THAT SHOULD BE MANAGED THROUGH THE COMPLAINT HANDLING SYSTEM. COMPLETE INFORMATION REGARDING THIS EVENT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766129 RINGLOC MODULAR ACETABULAR SYSTEM (SPIDERCUP, RIMCUP, BATCUP) PROSTHESIS, HIP PBI BIOMET SPAIN, S.L. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R