BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM ACETABULAR TRABECULAR METAL SHELL

    MDR report key: 2003649 · Received February 23, 2011

    Report

    Report Number
    1822565-2011-00390
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 27, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS REC'D FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE ZIMMER HIP REGISTRY STATED THAT THE PT HAD OSTEOPOROSIS. THE REGISTRY ALSO INDICATED THAT THE PT HAD A DYSCONJUGATE PELVIS. GIVEN THE INFORMATION PROVIDED, IT CAN BE CONCLUDED THAT EXPERIENCE OF PELVIC FRACTURE AND ACETABULAR IMPLANT LOOSENING WAS NOT DEVICE RELATED. THE OSTEOPOROSIS AND A DYSCONJUGATE PELVIS MAY HAVE CONTRIBUTED TO THE EXPERIENCE REPORTED; HOWEVER, A DEFINITIVE CAUSE CANNOT BE DETERMINED WITH CERTAINTY. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE REC'D, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO LOOSENING OF THE ACETABULAR COMPONENT AND A PELVIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM ACETABULAR TRABECULAR METAL SHELL JDI ZIMMER, INC. 61436555

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention LOT #61523417| LOT#61592486 MFG BY (B)(4)| CONTINUUM TRILOGY LONGEVITY HIGHLY CROSSLINKED| VERSYS FEMORAL HEAD, CATALOG #00801804001| POLYEHTYLENE LINER, CATALOG #00875101640| ZMR XL BODY, CATALOG #00992308345, LOT #60819365