BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM MODULAR ACETABULAR SHELL W/CLUSTER HOLES

    MDR report key: 2092604 · Received May 10, 2011

    Report

    Report Number
    1822565-2011-01150
    Event Type
    Injury
    Date Received
    May 10, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SURGICAL NOTES WERE PROVIDED FROM THE PRIMARY SURGERY ON (B)(6) 2006. BONE QUALITY OF THE FEMUR WAS DESCRIBED AS VERY MUSHY AND THERE WAS NO GOOD, CONSISTENT BONE. THE ACETABULAR SIDE WAS DESCRIBED AS HAVING SEVERAL CYSTS AND INCOMPETENT BONE. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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 RECEIVED, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS PRESENTING WITH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM MODULAR ACETABULAR SHELL W/CLUSTER HOLES JDI ZIMMER INC 60298183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other VERSYS FEMORAL HEAD: CATALOG #00801803202| CATALOG #00631005832, LOT #60375479| CATALOG #00992201823, LOT #60054206| ZMR XL TAPER STEM:| TRILOGY LONGEVITY CROSSLINKED POLYETHYLENE LINER:| ZMR XL BODY: CATALOG #0099231045, LOT # 60073595| LOT #60378591| MANUFACTURED BY ZIMMER (B)(6)