BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TRABECULAR METAL SHELL

    MDR report key: 3192008 · Received June 20, 2013

    Report

    Report Number
    1822565-2013-01002
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A USER FACILITY WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: IT IS UNK HOW THE PT "CAUGHT HIS LEG", AND IF THE PT WAS NOT ADHERING TO POST OPERATIVE HIP PRECAUTIONS AT THE TIME OF THE EVENT. ACCORDING TO THE PT'S HEIGHT AND WEIGHT PROVIDED, THE PT HAS A BMI OF (B)(6); A BMI OF 30 OR GREATER IS CONSIDERED OBESE. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) , AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT CAUGHT HIS LEG AND FELT SUBLUXATION. PHYSICAL EXAM AND X-RAYS WERE DONE WITH NO PROBLEMS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281624 CONTINUUM TRABECULAR METAL SHELL LZO ZIMMER, INC. 61821214

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other BIOLOX DELTA REMORAL HEAD: CAT #00877503602| LOT#61859198, MFG BY ZIMMER (B)(4)| LOT #2608747, MFG BY ZIMMER (B)(4)| CONTINUUM LONGEVITY NEUTRAL LINER:CAT#008751001136