BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY SHELL WITH CLUSTER HOLES

    MDR report key: 1881220 · Received October 5, 2010

    Report

    Report Number
    2648920-2010-00051
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    October 5, 2000
    Report Date
    September 23, 2010
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO REVISION SURGERY HAS TAKEN PLACE, SO NONE OF THE PARTS ARE AVAILABLE FOR EXAMINATION. OPERATIVE NOTES WERE PROVIDED AND INDICATE THAT THE PROPER SURGICAL TECHNIQUE WAS FOLLOWED AND NO COMPLICATIONS WERE ENCOUNTERED. ON THE TWO RETURNED X-RAYS (TAKEN (B)(6) 2008) NO ISSUES CAN BE SEEN THAT WOULD EXPLAIN THE PT'S CONDITION. THE ACTIVITY LEVEL OF PT AFTER SURGERY IS UNK. THE PT INFO INDICATES THAT HE IS OVERWEIGHT. WEIGHT AND/OR AN EXCESSIVE ACTIVITY LEVEL MAY HAVE CONTRIBUTED TO LOOSENING OR WEAR OF THE HIP IMPLANTS, CAUSING PAIN. THE PACKAGE INSERT FOR THIS SYSTEM STATES THAT COMPLICATIONS WHICH HAVE BEEN REPORTED INCLUDE INFLAMMATORY REACTIONS, PERIPHERAL NEUROPATHIES, SUBCLINICAL NERVE DAMAGE, AND PELVIC OR ACETABULAR FRACTURES. ONE OR A COMBINATION OF SEVERAL OF THESE COMPLICATIONS MAY BE RESPONSIBLE FOR CAUSING THE PAIN EXPERIENCED BY THIS PT. BASED ON THE INFO PROVIDED, A DEFINITIVE CAUSE FOR THIS ISSUE CANNOT BE DETERMINED. 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 THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE PT THAT THE PAIN STARTED THE DAY OF SURGERY AND IS ONGOING. HE CAN'T WALK ON HIS HIP AND HAS TOTAL DISCOMFORT; CAN'T PUT ANY WEIGHT ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY SHELL WITH CLUSTER HOLES HIP PROSTHESIS JDI ZIMMER 20526200

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED| CATALOG #00902602900, LOT #15257900| ZIMMER ANATOMIC FEMORAL STEM| CATALOG #00630505628, LOT #67465100| CATALOG #00660001522, LOT #62900500| ZIMMER FEMORAL HEAD| POLYETHYLENE LINER