BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 3921520 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06004
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 18, 2014
    Report Date
    October 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTED INFORMATION: EVENT DESCRIPTION: PATIENT DID NOT UNDERGO LEFT FEMORAL RESURFACING ON (B)(6) 2006 OR A REVISION PROCEDURE ON (B)(6) 2009.

    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. PRODUCT IDENTIFICATION/EXPIRATION DATE - UNKNOWN. PMA/510(K) NUMBER - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE WILL OCCUR. 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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-06004 AND 08213).

    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.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT RIGHT FEMORAL RESURFACING ON (B)(6) 2006. SUBSEQUENTLY, THE PATIENT RADIOGRAPHS REVEALED A REACTIVE STEM LINE INDICATIVE OF FEMORAL LOOSENING AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2006. SUBSEQUENT RADIOGRAPHS REVEALED A REACTIVE STEM LINE INDICATIVE OF FEMORAL LOOSENING. A REVISION PROCEDURE WAS REPORTED TO HAVE BEEN SCHEDULED; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. A REVIEW OF INVOICE HISTORY COULD NOT CONFIRM THE INITIAL SURGERY DATE.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT RIGHT FEMORAL RESURFACING ON (B)(6) 2006. SUBSEQUENTLY, THE PATIENT RADIOGRAPHS REVEALED A REACTIVE STEM LINE INDICATIVE OF FEMORAL LOOSENING AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2014. A REVIEW OF INVOICE HISTORY COULD NOT CONFIRM THE INITIAL SURGERY DATE. ADDITIONAL INFORMATION RECEIVED ON PRODUCT IDENTIFICATION FOR THE RIGHT FEMORAL RESURFACING PERFORMED ON (B)(6) 2006. ADDITIONAL INFORMATION RECEIVED ON CLINICAL STUDY INDICATES PATIENT UNDERWENT LEFT FEMORAL RESURFACING ON (B)(6) 2006. FURTHER INFORMATION RECEIVED ON CLINICAL STUDY INDICATES A REVISION SURGERY PERFORMED ON (B)(6) 2009 ON AN UNKNOWN SIDE FOR AN UNKNOWN REASON.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT RIGHT FEMORAL RESURFACING ON (B)(6) 2006. SUBSEQUENTLY, THE PATIENT RADIOGRAPHS REVEALED A REACTIVE STEM LINE INDICATIVE OF FEMORAL LOOSENING AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2014. A REVIEW OF INVOICE HISTORY COULD NOT CONFIRM THE INITIAL SURGERY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401159 UNKNOWN HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R