BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS MEN BEARING UHMWPE SMALL SZ 4

    MDR report key: 2821416 · Received November 6, 2012

    Report

    Report Number
    3002806535-2012-00332
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 10, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. ITEM WAS NOT RETURNED TO THE MANUFACTURER. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. (B)(4) - DEVICE EVALUATION IN PROCESS. UPON COMPLETION OF EVALUATION, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE RETURNED BEARING WAS EVALUATED AND FOUND WEAR ON BOTH THE SUPERIOR AND INFERIOR ARTICULATING SURFACES OF THE BEARING. THE SUPERIOR WEAR APPEARS TO BE A GOUGE, POSSIBLY AS A RESULT OF THE EDGE OF THE FEMORAL COMPONENT DIGGING IN, WHICH IS LIKELY TO HAVE OCCURRED WHEN IN DEEP FLEXION. THE INFERIOR WEAR APPEARS TO HAVE BEEN AS A RESULT OF TIBIAL OVERHANG, SUGGESTED BY THE PROVIDED RADIOGRAPHS. ALTHOUGH NOT VISIBLE ON THE RADIOGRAPHS, IT IS POSSIBLE THIS OVERHANG CAUSED BONE IMPINGEMENT OF THE BEARING. THE VISIBLE OVERHANG ON THE RADIOGRAPHS WOULD HAVE CAUSED NON-CONGRUENT ARTICULATION. THE RESULTING UNSUPPORTED REGION OF THE BEARING MAY THEN HAVE EXPERIENCED ELEVATED STRESSES, WHICH WOULD HAVE CONTRIBUTED TO THE WEAR NOW APPARENT. THE INCREASED WEAR OF THE BEARING RESULTED IN A MARKED REDUCTION IN THICKNESS, WHICH WILL HAVE INEVITABLY RESULTED IN A LOWER STRENGTH OF THE BEARING. STRESSES WOULD HAVE BEEN ELEVATED FURTHER, LEADING TO ITS EVENTUAL FAILURE. THE WEAR ON THE MEDIAL SIDE OF THE BEARING IS POSSIBLY DUE TO ARTICULATION AGAINST TISSUES CAUSED BY THE LOCATION OF THE BEARING IN THE JOINT. THE RADIOGRAPHS SHOW THE BEARING TO BE POSITIONED MEDIALLY, WHICH WOULD HAVE CONTRIBUTED TO THE BEARING OVERHANGING THE TIBIAL TRAY; HOWEVER, THE FEMORAL COMPONENT DOES NOT APPEAR TO BE MALALIGNED WITH RESPECT TO THE FEMORAL CONDYLES. THE BEARING FAILED AS A RESULT OF FRACTURE, PROBABLY AS A RESULT OF ADVERSE WEAR. THE WEAR WAS LIKELY A RESULT OF A COMBINATION OF FACTORS, INCLUDING APPARENT IMPINGEMENT AND INCONGRUENT ARTICULATION DUE TO BEARING MEDIALIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY OXFORD KNEE PROCEDURE IN 2004. REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2011 DUE TO DISLOCATION. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD PKS MEN BEARING UHMWPE SMALL SZ 4 OXFORD TIBIAL BEARING NRA BIOMET UK LTD. N/A 620749

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R