BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL HIP SYSTEM TAPER CEMENTED STEM

    MDR report key: 2010529 · Received March 1, 2011

    Report

    Report Number
    1822565-2011-00441
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICES WERE IN VIVO FOR APPROX 9 YRS AND 3 MONTHS. DEVICES WERE NOT AVAILABLE FOR RETURN; THEREFORE, THEY COULD NOT BE ANALYZED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR OSTEOLYSIS. X-RAYS SHOWED BONE LOSS AROUND CEMENTED STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL HIP SYSTEM TAPER CEMENTED STEM HIP PROSTHESIS JDI ZIMMER, INC. 1454209

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHELL WITH SEALED SCREW HOLES, CATALOG # 436000053| INSERT, CATALOG # 437228053, LOT # 1422232| INTER-OP ACETABULAR SYSTEM HEMISPHERICAL POROUS| LOT # 1484836| METASUL FEMORAL HEAD NEUTRAL NECK,| CATALOG # 734028000, LOT # 1453037| INTER-OP ACETABULAR SYSTEM METASUL STANDARD