BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 2051502 · Received April 7, 2011

    Report

    Report Number
    1822565-2011-00879
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 30, 1999
    Report Date
    March 11, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE OP NOTES INDICATE THAT A TRILOGY MULTI HOLED CUP WAS IMPLANTED WITH A "SOLUTION" STEM (MOST LIKELY NON-ZIMMER). THE OP NOTES FROM (B)(6) 1999, WERE REVIEWED WHERE THE SURGEON REDUCED THE PT'S HIP. THE SURGEON STATED THAT "IT LOOKED LIKE AN 8" SOLUTION STEM THAT WOULD APPEAR TO HAVE SETTLED ABOUT 3/4" FROM THE CENTER OF HEAD BEING LEVEL WITH THE TIP OF THE GREATER TROCHANTER." IT WAS STATED THAT " IT APPEARS BY X-RAY BECAUSE OF THE PROMINENCE OF THE GREATER TROCHANTER AS A RESULT OF THE IMPLANT SHORTENING THAT HE IS PROBABLY LEVERING WITH EXTERNAL ROTATION THE GREATER TROCHANTER AGAINST THE PELVIS CAUSING THE IMPLANT TO BE DISLOCATED ANTERIORLY." THIS IS ONE POTENTIAL ROOT CAUSE IDENTIFIED BY THE SURGEON THAT ASSESSED THE PT'S CONDITION AND APPLICABLE X-RAYS. WITH THE AVAILABLE INFO IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF DISLOCATION. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT UNDERWENT REDUCTION BY EXTENSION AND INTERNAL ROTATION UNDER TRACTION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER HIP HIP PROSTHESIS JDI ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention