BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY SHELL WITH CLUSTER HOLES

    MDR report key: 1970906 · Received January 4, 2011

    Report

    Report Number
    1822565-2010-01463
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Report Date
    December 8, 2010
    Manufacturer
    ZIMMER INC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: WITH THE INFO PROVIDED NO CONCLUSION OR PROBABLE CAUSE FOR THE PT'S PAIN CAN BE DETERMINED. EVAL: 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. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY SHELL WITH CLUSTER HOLES HIP PROSTHESIS LPH ZIMMER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE SCREW SELF-TAPPING| POLYETHYLENE LINER| VERSYS HIP SYSTEM FEMORAL HEAD| CATALOG# 00625006530, LOT# UNK| TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED| CATALOG# 00784301206, LOT# UNK| CATALOG# 00801803202, LOT# UNK| CATALOG# 00631005632, LOT# UNK| VERSYS HIP SYSTEM FEMORAL STEM