BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELF CENT HIP 42X28 RUST

    MDR report key: 4192545 · Received October 22, 2014

    Report

    Report Number
    1818910-2014-30419
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK812672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ONE IMAGE OF A RADIOGRAPH WAS RETURNED FOR ANALYSIS ALONG WITH AN EXPLANTED FEMORAL HEAD (ARTICULEZE 28+1.5) AND SELF-CENTERING BIPOLAR HIP (42 MM). THE X-RAY IMAGE CLEARLY SHOWS THE HEAD DISLOCATED FROM THE SELF-CENTERING CONSTRUCT. THE CUP IS ROTATED TO FACE SUPEROLATERALLY. THE CUP POSITIONING DOES NOT INDICATE THAT THE CUP FAILED; THE CUP IS DESIGNED TO ARTICULATE WITHIN THE ACETABULUM. NO OTHER ANOMALIES OR ISSUES WERE NOTED IN THE IMAGE. THE BIPOLAR CONSTRUCT CONSISTS OF THREE COMPONENTS: CUP, LINER, AND LOCKING RING. THE LOCKING RING IS DESIGNED TO HOLD THE HEAD WITHIN THE CUP. ON THE RETURNED INSTRUMENT THE MATING FEATURE THAT LOCKS THE RING INTO THE LINER HAS BEEN COMPLETELY SHEARED OFF, ALLOWING THE LOCKING RING AND FEMORAL HEAD TO COME LOOSE FROM THE CUP AND LINER. NOT ONLY WOULD SIGNIFICANT FORCES HAVE BEEN REQUIRED TO SHEAR AWAY THIS MATING FEATURE, BUT THE CUP WOULD HAVE HAD TO RESIST THE FORCE AND REMAINED STATIONARY. IF THE CUP HAD NOT BEEN LODGED IN PLACE, THE FORCES WOULD HAVE RESULTED IN ROTATIONAL MOVEMENT RATHER THAN COMPONENT FAILURE. IT IS NOT CLEAR WHAT SECURED THE HEAD IN PLACE. HOWEVER, BECAUSE THE APEX OF THE HEAD IS ROTATED INFEROMEDIALLY IN THE X-RAY IMAGE, THE OBSTRUCTION WAS PROBABLY NOT INFERIOR TO THE CUP. IT IS LIKELY THAT THE OBSTRUCTION OCCURRED SUPEROLATERALLY, INHIBITING THE HIP FROM ADDUCTING AND TRANSFERRING THE ADDUCTING FORCE DIRECTLY TO THE POLY LOCKING RING AS THE FEMORAL HEAD PUSHED LATERALLY. THE PATIENT IS CONSIDERED OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TENDS TO ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION. THE LOCKING RING WAS ALSO FOUND TO BE BROKEN.

    Description of Event or Problem · 1

    UPDATE REC'D 10/24/2014 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. PRIOR TO REVISION THE PATIENT WAS EXPERIENCING PAIN. RECORDS INDICATE UPON REVISION POLY DEBRIS WAS REMOVED FROM THE HIP. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. DOI: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671675 SELF CENT HIP 42X28 RUST HIP OTHER IMPLANT KWY DEPUY ORTHOPAEDICS, INC. D5DHA1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention