BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM M2A MOD HEAD +6MM NK

    MDR report key: 3041448 · Received April 8, 2013

    Report

    Report Number
    0001825034-2013-00882
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    April 3, 2013
    Report Date
    October 27, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. DATE OF EVENT - (B)(6) 2013. DATE EXPLANTED - (B)(6) 2013.

    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 - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. PMA/510(K) NUMBER / MANUFACTURE DATE - UNKNOWN.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THESE TYPES OF EVENTS CAN OCCUR UNDER POSSIBLE ADVERSE EFFECTS: 1) MATERIAL SENSITIVITY REACTIONS. 6) INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS. 14) POSTOPERATIVE BONE FRACTURE AND PAIN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-00882 AND 2014-06094).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTION: LEGAL COUNSEL REPORTED DATE FOR THE RIGHT TOTAL HIP ARTHROPLASTY HAS BEEN CORRECTED IN THIS REPORT FROM (B)(6) 2011 TO READ (B)(6) 2001.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, IT WAS REPORTED THAT A REVISION IS RECOMMENDED DUE TO UNKNOWN REASONS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, IT WAS REPORTED PATIENT WAS REVISED IN (B)(6) 2013 DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, IT WAS REPORTED PATIENT WAS REVISED IN (B)(6) 2013 DUE TO AN UNKNOWN REASON. LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, LEGAL COUNSEL REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE/TISSUE, AND IMPAIRMENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, IT WAS REPORTED PATIENT WAS REVISED IN (B)(6) 2013 DUE TO AN UNKNOWN REASON. LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, LEGAL COUNSEL REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE/TISSUE, AND IMPAIRMENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE (OP) REPORT DATED (B)(6) 2013 REPORTS PATIENT WAS REVISED ON THE RIGHT HIP DUE TO PSEUDOTUMOR, TORN ABDUCTOR TENDONS, AND WEAKNESS IN ABDUCTOR MUSCULATURE. REVISION OP REPORT NOTES THE PRESENCE OF CLEAR AND BROWNISH-CLEAR SEROSANGUINEOUS FLUID, ABDUCTOR TENDON DEFECT, NON UNION IN THE TROCHANTER, FRAGMENTED TROCHANTER, NECROTIC BONE AND TISSUE, PROXIMAL FEMUR OSTEOLYSIS, METAL CORROSION AT THE TAPER, AND POSTERIOR-SUPERIOR AND ANTERIOR WALL VOIDS. THE HEAD AND TAPER INSERT WERE REMOVED AND REPLACED. THE SHELL WAS REMOVED AND REPLACED WITH COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143767 28MM M2A MOD HEAD +6MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 534540

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R