BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIPOLAR BIPOLAR LINER

    MDR report key: 1931626 · Received November 22, 2010

    Report

    Report Number
    1822565-2010-01170
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE DEVICE REMAIN IMPLANTED, SO THEY WERE NOT RETURNED FOR EVAL. OPERATIVE NOTES FROM THE PRIMARY SURGERY WERE PROVIDED. NO X-RAYS WERE RETURNED. PT AGE IS UNK, BUT HEIGHT, WEIGHT, AND ACTIVITY LEVEL ARE UNK. IT IS UNK IF THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION PER THE SURGICAL TECHNIQUES. THE CONDITION OF THE IMPLANTS IS UNK. THE INSTRUMENTATION USED IN THE SURGERY IS UNK. IT IS ALSO UNK IF THE PT FOLLOWED THE PROPER REHABILITATION PROTOCOLS. BASED ON THE INFO PROVIDED, IT IS NOT POSSIBLE TO DETERMINE A CAUSE FOR THE PAIN WITH CERTAINTY. EVAL: 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT BEGAN EXPERIENCING PAIN APPROXIMATELY 9 MONTHS POST-OP AND THAT IT HAS INCREASED SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIPOLAR BIPOLAR LINER HIP PROSTHESIS JDI ZIMMER 60399430

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR VERSYS HIP SYSTEM FEMORAL STEM| VERSYS HIP SYSTEM FEMORAL HEAD| MULTIPOLAR BIPOLAR CUP SHELL| (B)(4)| LOT# 60580210| CATALOG# 00783301400| LOT#60535572| CATALOG# 00801802814| CATALOG# 00785901200| VERSYS HIP SYSTEM DISTAL CENTRALIZER| (B)(4)| LOT# 74443400| LOT#60661939| CATALOG# 00500105200