BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TRABECULAR METAL SHELL

    MDR report key: 3261264 · Received July 31, 2013

    Report

    Report Number
    1822565-2013-01169
    Event Type
    Injury
    Date Received
    July 31, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PRIMARY OPERATIVE NOTES WERE PROVIDED AND ARE UNREMARKABLE. X-RAY ANALYSIS REVEALS A WELL-ALIGNED AND WELL-FIXED RIGHT TOTAL HIP REPLACEMENT. AN ANALYSIS OF THE 6 WEEKS X-RAY REVEALED THAT THE ACETABULAR COMPONENT WAS PLACED IN THE APPROPRIATE DEGREE OF INCLINATION. IN GENERAL, PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL IS NOTED AS 'HOME EXERCISE'; HOWEVER THE PT'S ADHERENCE THERETO IS UNK. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVAL: 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. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS DIAGNOSED WITH PSOAS TENDONITIS AND EXPERIENCED RIGHT GROIN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357111 CONTINUUM TRABECULAR METAL SHELL LZO ZIMMER, INC. 62146212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MANUFACTURED BY ZIMMER (B)(4)| (B)(4).| LOT# 2667878| MANUFACTURED BY ZIMMER (B)(4)| BIOLOX DELTA HEAD: CATALOG# 00877503601,| LONGEVITY LINER: CATALOG# 00875101336,| LOT# 62184374| ZIMMER M/L FEMORAL STEM: CATALOG# 00771101320,| LOT# 62200499