BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULZER INTER-OP RIM FLARE POROUS SHELL

    MDR report key: 2082950 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01111
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    February 15, 2000
    Report Date
    April 4, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. NO FLUID WAS OBTAINED FROM THE JOINT CAVITY DURING ASPIRATION. PRIOR TO PROCEDURE, THE HIP WAS THOUGHT TO BE INFECTED. SURGICAL NOTES WERE PROVIDED FROM THE PRIMARY SURGERY ON (B)(6) 1999. NO COMPLICATIONS WERE NOTED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNK. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNK. ADHERENCE TO REHAB PROTOCOL IS UNK. SINCE NO FLUID WAS OBTAINED, IT COULD NOT BE DEFINITIVELY DETERMINED IF THE HIP WAS INFECTED. 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. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT ARTHROGRAM AND ASPIRATION OF THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SULZER INTER-OP RIM FLARE POROUS SHELL HIP PROSTHESIS KWB ZIMMER, INC. 1326355

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention SULZER INTER-OP ACETABULAR HOODED INSERT:| SULZER NATURAL-HIP COLLARED POROUS STEM:| SULZER TOTAL HEAD:| CATALOG #436528049, LOT #1334767| CATALOG #721028004, LOT #1332552| CATALOG #735601202, LOT #1331998