BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENT FMRL HD RESUR 52M

    MDR report key: 3924478 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06028
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    August 26, 2007
    Report Date
    October 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KXA
    PMA / PMN Number
    PK021799
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: EVENT DESCRIPTION ¿ PATIENT WAS NOT ENROLLED IN A CLINICAL STUDY. A RETROSPECTIVE CLINICAL REVIEW IDENTIFIED THE PATIENT¿S EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT. PRODUCT / LOT CODE / EXPIRATION DATE. PMA/510(K) NUMBER. MANUFACTURE DATE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A SURGICAL COMPLICATION OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06028 AND 08601).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2007 DUE TO INFECTION AND WOUND BREAKDOWN FIVE MONTHS POST OP. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT SEVERAL RADICAL DEBRIDEMENT PROCEDURES ON UNKNOWN DATES.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2007 DUE TO INFECTION AND WOUND BREAKDOWN FIVE MONTHS POST OP. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT SEVERAL RADICAL DEBRIDEMENT PROCEDURES ON UNKNOWN DATES.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2007 DUE TO INFECTION AND WOUND BREAKDOWN FIVE MONTHS POST OP. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT SEVERAL RADICAL DEBRIDEMENT PROCEDURES ON UNKNOWN DATES. PRODUCT IDENTIFICATION IS NOW KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401666 RECAP CEMENT FMRL HD RESUR 52M PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 897250

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R