BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P4 28MM 10DEG INSERT OSTEOLOCK

    MDR report key: 1900047 · Received November 9, 2010

    Report

    Report Number
    2249697-2010-01501
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K990849
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVAL: IT WAS REPORTED THAT THE PT HAD THE HEAD AND LINER REPLACED. IT WAS FURTHER REPORTED THAT THE REVISION WAS DUE TO EXCESSIVE POLY WEAR OF THE LINER AND PT PAIN. THE REPORTED DEVICES WERE NOT RETURNED FOR EVAL. NO ANY MEDICAL RECORDS AND X-RAYS WERE PROVIDED. THE RESULTS OF THE INVESTIGATION INDICATE THAT THE POLY WEAR OF THE LINER IS EXPECTED, ESPECIALLY AFTER IT HAS BEEN IMPLANTED FOR APPROX 15 YRS. THE REASON OF PT PAIN CANNOT BE DETERMINED WITH THE LIMITED INFO PROVIDED. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PT HAD AN OSTEOLOCK/VITALOCK PRIMARY IN SINCE 1995. SURGEON DECIDED TO REPLACE THE HEAD (28MM 0 TO A 32 +5MM CHROME COBALT) AND LINER FROM A 28 P4 10 DEG TO A 32MM 10 DEG P4 CROSSFIRE. THE CASE WAS UNEVENTFUL AND ROUTINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P4 28MM 10DEG INSERT OSTEOLOCK IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R