BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2001647 · Received February 22, 2011

    Report

    Report Number
    2249697-2011-00197
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR #S 2249697-2011-00198 AND 9616680-2011-00079.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "(B)(6) MALE TREATED FOR AVN WITH A TOTAL HIP ARTHROPLASTY. THE PATIENT DID WELL IN THE IMMEDIATE POSTOPERATIVE PERIOD FOR AT LEAST 6 MONTHS, FELT A POP, BUT THEN EXPERIENCED SOME PAIN IN THE LEFT HIP THEREAFTER, BUT DID NOT BECOME SERIOUS PAIN UNTIL (B)(6) 2010. THE PATIENT HAD AN ASPIRATION DONE IN THE LAST WEEK OF (B)(6) AND DUE TO SOME DIFFICULTIES WITH THE PROCESS, IT WAS UNDECIDED AS TO WHETHER THE PATIENT DID INDEED HAVE AN "EXTREMELY LIGHT GROWTH" OF (B)(6) IN BROTH. THIS WAS COUPLED WITH THE FACT THAT HE HAD NO CELLS SEEN IN THE ASPIRATE AND NEGATIVE GRAIN STAIN AND NO BACTERIA SEEN. PATIENT'S C-REACTIVE PROTEIN WAS 1.5. SED RATE WENT UP TO 70 AFTER BEING 30. THIS WAS FOLLOWING THE ASPIRATION. THE PATIENT CONTINUED WITH ONGOING PAIN. THERE WAS FURTHER WORKUP WITH A REPEAT MARS EXAM TO SEE IF THE FLUID STILL REMAINED. THERE WAS STILL FLUID IN THE SOFT TISSUES AND THEREFORE, DECIDED FOR RE-ASPIRATION FOR A SECOND LOOK. DURING REVISION, WE NOTICED CORROSION AT THE HEAD/NECK JUNCTION OF THE STEM WHICH RESEMBLED THAT OF A BLACK RUST. THE CORROSION IS SOMETHING OF GREAT CONCERN. FROM THIS POINT, STEM, NECK, AND FEMORAL HEAD (SIZE 7 STEM, 38MM/YELLOW/8 DEGREES OF ANTEVERSION, 36MM/STD BIOLOX DELTA HEAD) WAS REPLACED WITH SIZE 8, 38MM/YELLOW/8 DEGREES OF ANTEVERSION, 36MM/STD BIOLOX DELTA FEMORAL HEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA MHP3EM

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R