BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL SHELL WITH CLUSTER HOLES

    MDR report key: 1990888 · Received February 8, 2011

    Report

    Report Number
    1822565-2011-00193
    Event Type
    Injury
    Date Received
    February 8, 2011
    Report Date
    January 11, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICES WERE IMPLANTED ON (B)(6) 2008, PLACING THEM IN SERVICE FOR APPROX TWO YRS AND TWO MONTHS AT TIME, THE EXPERIENCE WAS REPORTED. NO X-RAYS OR SURGICAL NOTES WERE PROVIDED TO SUPPORT THE COMPLAINT ALLEGATION. WITH THE INFO PROVIDED NO CONCLUSION OR PROBABLE CAUSE FOR THE PT'S PAIN CAN BE DETERMINED. EVAL 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN. REVISION STATUS IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL SHELL WITH CLUSTER HOLES LPH ZIMMER INC 61026796

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT #60559814, MANUFACTURED AT ZIMMER B.V.,| VERSYS FEMORAL HEAD, CATALOG #00801803214,| (B)(4)| SELF TAPPING BONE SCREW, CATALOG #00625006530,| ZIMMER M/L TAPER FEMORAL STEM,| LONGEVITY CROSSLINKED POLYETHYLENE OFFSET LINER,| (B)(4)| LOT #61002415, MANUFACTURED AT ZIMMER B.V.,| CATALOG #00634104832, LOT #60189216| (B)(4)| CATALOG #00771100920, LOT #61025003| SELF TAPPING BONE SCREW, CATALOG #00625006520,| LOT #61056192, MANUFACTURED AT ZIMMER B.V.,