BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 36IDX52OD

    MDR report key: 2151032 · Received June 29, 2011

    Report

    Report Number
    1818910-2011-11266
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K033273
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE UNAVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. REPEATED ATTEMPTS TO OBTAIN THE COMPLAINT SAMPLES PROVED UNSUCCESSFUL. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND / OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EXAMINATION OF THE RETURNED DEVICES FINDS WEAR PATTERNS ON THE FEMORAL HEAD CONFIRMING THE LINER DISASSOCIATED AND CONTACTED THE ACETABULAR CUP. MATCHING WEAR IS FOUND ON THE ACETABULAR CUP. THE RETURNED LINER ALSO SHOWS SIGNS OF UNUSUAL WEAR, FOUR OF THE ARDS HAVE BEEN FRACTURED, FURTHER INDICATING THE ECCENTRIC LOADING. SUBSTANTIAL EDGE WEAR IS NOTED. 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. THE EDGE LOADING OF THE LINER HAS PLACED PRESSURES ON THE MATERIAL NEAR THE RIM THAT WERE NOT INTENDED LEADING TO A FRACTURE OF THE MATERIAL AND SUBSEQUENT DISASSOCIATION OF THE LINER FROM THE CUP. PREVIOUS REVIEW OF PROVIDED PATIENT X-RAYS FOUND ECCENTRIC LOADING IS CONFIRMED. NO ISSUE WITH ACETABULAR PLACEMENT OR ANGLE WAS NOTED. IT WAS FOUND THAT NO LINE FROM LOCKING ON THE TAPER IS SEEN, INDICATING THE LINER MAY NOT HAVE BEEN FULLY SEATED. A REVIEW OF THE DHR (DEVICE HISTORY RECORD) FOR PRODUCT NUMBER 136552000 LOT NUMBER 3010300 FOUND NO ANOMALIES. THE PATIENT IS A REPORTED FEMALE WITH A CALCULATED BMI OF (B)(6). THE PATIENT IS CONSIDERED OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TENDS TO ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS. THE INVESTIGATION CAN DRAW NO FURTHER CONCLUSIONS WITH THE INFORMATION PROVIDED. PRODUCT PROBLEM HAS NOT BEEN INDICATED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED.

    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.

    Description of Event or Problem · 1

    DISASSOCIATION OF PINNACLE LINER FROM SHELL, REQUIRING REVISION OF LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MAR +4 10D 36IDX52OD 87 LPH LPH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention