BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM MODULAR ACETABULAR SHELL W/CLUSTER HOLES

    MDR report key: 2023279 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00624
    Event Type
    Injury
    Date Received
    February 15, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. 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 AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNK. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. THERE IS INSUFFICIENT INFORMATION TO PERFORM A PROBABLE CAUSE ANALYSIS. EVALUATION: REVIEW O F 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 REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS PRESENTING WITH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM MODULAR ACETABULAR SHELL W/CLUSTER HOLES LPH ZIMMER, INC. 61262524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4)| TRILOGY LONGEVITY CROSSLINKED POLYETHYLENE LINER| LOT #61213751 - (B)(4)| CATALOG #00630505036, LOT #61289840| VERSYS FEMORAL HEAD, CATALOG #00801803602