BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C.* 28MM HEAD +10MM

    MDR report key: 2921327 · Received January 18, 2013

    Report

    Report Number
    1818910-2013-11146
    Event Type
    Injury
    Date Received
    January 18, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. ? REG. # 8010379
    Product Code
    KWY
    PMA / PMN Number
    PK893872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. DURING REVIEW OF MEDICAL RECORDS RECEIVED BY THE LEGAL DEPARTMENT, IT WAS DISCOVERED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2001 - DOR: (B)(6) 2003 AND AGAIN ON (B)(6) 2003. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE ITS RELEASE FOR DISTRIBUTION. THE PATIENT IS A REPORTED FEMALE, BORN (B)(6) 1936, WITH A CALCULATED BMI OF (B)(6). THE PATIENT IS CONSIDERED MORBIDLY OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TENDS TO ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS. MEDICAL RECORDS WERE OBTAINED. THE DEPUY LEGAL NURSE STATES, FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION MADE AVAILABLE, IT IS UNLIKELY THAT THE COMPLAINTS LISTED HERE ARE PRODUCT RELATED. THERE IS A RISK OF FAILURE WITH ANY TOTAL JOINT ARTHROPLASTY THAT IS A COMBINATION OF PATIENT FACTORS, SURGICAL PROCESS AND SURGICAL TECHNIQUE. THERE ARE NUMEROUS PATIENT FACTORS THAT COMPLICATED AND CONTRIBUTED TO THESE REVISIONS. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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

    DURING REVIEW OF MEDICAL RECORDS RECEIVED BY THE LEGAL DEPARTMENT, IT WAS DISCOVERED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27921 P.F.C.* 28MM HEAD +10MM FEMORAL HEAD KWY DEPUY INTERNATIONAL LTD. ? REG. # 8010379 XLE16

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention