BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 NEUT 40IDX60OD

    MDR report key: 4093336 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28204
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK033273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. 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

    (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

    EXAMINATION OF THE REPORTED DEVICES CONFIRMS THE REPORTED LOCKING RING FRACTURE. IT IS EVIDENT THE ACETABULAR LINER WAS ECCENTRICALLY LOADED. THERE ARE MACHINING LINES YET VISIBLE WITHIN THE INNER RADIUS OF THE LINER WHICH WOULD NOT BE AS OBVIOUSLY PRESENT HAD THE FEMORAL HEAD BEEN MORE CENTRALLY LOADED. DAMAGE SEEN ON THE RETURNED SELF CENTERING HIP AND FEMORAL HEAD CONFIRMS THE REPORTED SUBLUXATION AND/OR DISLOCATION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. MEDICAL RECORDS AND X-RAYS WERE PROVIDED AND REVIEWED. RADIOGRAPHS DATED (B)(6) 2014 CONFIRM PLACEMENT OF THE REVISED COMPONENTS. WITH THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THE COMPLAINT IS PRODUCT RELATED. THE DISLOCATION COULD BE A RESULT OF THE MALPOSITIONED IMPLANTS IMPROPERLY LOADING THE COMPONENTS. THE INVESTIGATION CAN DRAW NO FURTHER CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.(B)(4)

    Description of Event or Problem · 1

    PATIENT LUXATED SEVERAL TIMES AND FIRST LINER/HEAD REVISION IN 2009, WHERE THE NOW REVISED LINER/HEAD WAS INSERTED. PATIENT LUXATED DURING A HOLIDAY IN SPRING AND PUT IN PLACE AT THE HOLIDAY SITE. AGAIN LUXATED 2 MONTH LATER, THE SURGEON AT (B)(6) FOUND THAT SOMETHING WAS WRONG ON THE X-RAY, AND DECIDED TO OPERATE. FOUND THAT THE LOCKING RING WAS BROKEN OF FROM THE PE IN THE SELFCENTRING HEAD. CUP AND STEM WELL FIXED, AND THEY INSERTED A NEW MARATHON LINER AND SELFCENTRING HEAD. WE HAVE RECEIVED SEVERAL DIGITAL X-RAYS AND OPERATION NOTES, AND HAVE THE IMPLANTS - WITHOUT ANY PATIENT IDENTIFICATION, ANONYMOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571216 PINN MAR +4 NEUT 40IDX60OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention