BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD STD NK

    MDR report key: 2974435 · Received February 22, 2013

    Report

    Report Number
    0001825034-2013-00335
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    September 25, 2008
    Report Date
    February 3, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-00334 / 00335).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "MATERIAL SENSITIVITY REACTIONS. " THIS REPORT IS NUMBER 2 OF 4 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-00334 / 00335 & 2015-00528 /-00529).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, AND LOSS OF RANGE OF MOTION. LEGAL COUNSEL FOR PATIENT FURTHER ALLEGES PATIENT UNDERWENT A REVISION ON (B)(6) 2008 AND UNDERWENT A SECOND REVISION ON (B)(6)2010. A REVIEW OF INVOICE HISTORY CONFIRMS ALL SURGERY DATES AND THAT THE CUP AND HEAD WERE REMOVED AND REPLACED ON (B)(6) 2008. INVOICE HISTORY ALSO INDICATES THE HEAD AND LINER WERE REPLACED DURING THE REVISION PROCEDURE ON (B)(6) 2010. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, AND LOSS OF RANGE OF MOTION. LEGAL COUNSEL FOR PATIENT FURTHER ALLEGES PATIENT UNDERWENT A REVISION ON (B)(6) 2008 AND UNDERWENT A SECOND REVISION ON (B)(6) 2010. A REVIEW OF INVOICE HISTORY CONFIRMS ALL SURGERY DATES AND THAT THE CUP AND HEAD WERE REMOVED AND REPLACED ON (B)(6) 2008. INVOICE HISTORY ALSO INDICATES THE HEAD AND LINER WERE REPLACED DURING THE REVISION PROCEDURE ON (B)(6) 2010. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S RIGHT REVISION OPERATIVE REPORT FROM 2008 WAS DUE TO ALVAL HYPERSENSITIVITY, METAL-ON-METAL REACTION AND NECROTIC AVULSION OF ABDUCTOR MECHANISM. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF A GRAY STAINED FEMORAL FASCIA, GREENISH TINGED INFLAMMATORY SEROUS EXUDATES INDICATING ALVAL HYPERSENSITIVITY REACTION, LOOSE ABDUCTORS, NECROTIC INFLAMMATORY REACTION, EXTENSION-TYPE IMPINGEMENT, AND BURNISHING ON THE HEAD AND CUP. THE ACETABULAR CUP AND MODULAR HEAD REPLACED WITH A CUP, POLYETHYLENE LINER AND MODULAR HEAD. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT FROM (B)(6) 2010 INDICATES THE REVISION PROCEDURE WAS DUE TO DISLOCATION. REVISION OPERATIVE REPORT NOTED A DETACHED ILIOTIBIAL BAND AND STAINED TISSUE. THE LINER AND MODULAR HEAD WERE REMOVED AND REPLACED WITH A CONSTRAINED HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78238 M2A 38MM MODULAR HEAD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 120880

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R