BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIV SOLID RNGLC SHL 46MM L22

    MDR report key: 3824988 · Received May 21, 2014

    Report

    Report Number
    0001825034-2014-04475
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    June 3, 2004
    Report Date
    August 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK921301
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    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

    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 9 STATES, ¿FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." NUMBER 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS NUMBER 3 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04358 & 04474 / 04477).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2000 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN AND SWELLING. SUBSEQUENTLY, PATIENT UNDERWENT A LEFT REVISION PROCEDURE ON (B)(6) 2004 DUE PATIENT ALLEGATIONS OF PAIN, SWELLING, FRAGMENTATION OF THE ACETABULAR CUP, METAL DEBRIS, HETEROTOPIC BONE FORMATION AND FEMORAL HEAD AND LINER WEAR. IT WAS REPORTED THE MODULAR HEAD, LINER AND ACETABULAR CUP WERE REMOVED AND REPLACED. LEGAL COUNSEL REPORTED PATIENT ALLEGATIONS OF PAIN IN BOTH HIPS IN 2008. SUBSEQUENTLY, PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF OSTEOLYSIS, ACETABULAR CYST, SYNOVITIS, METALLOSIS, DEGENERATED AND NECROTIC SYNOVIUM AND FOCAL FOREIGN BODY GIANT CELL REACTION. THE MODULAR HEAD, LINER, AND ACETABULAR CUP WERE REMOVED AND REPLACED. LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF METAL POISONING. 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 PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2000 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN AND SWELLING. SUBSEQUENTLY, PATIENT UNDERWENT A LEFT REVISION PROCEDURE ON (B)(6) 2004 DUE PATIENT ALLEGATIONS OF PAIN, SWELLING, FRAGMENTATION OF THE ACETABULAR CUP, METAL DEBRIS, HETEROTOPIC BONE FORMATION AND FEMORAL HEAD AND LINER WEAR. IT WAS REPORTED THE MODULAR HEAD, LINER AND ACETABULAR CUP WERE REMOVED AND REPLACED. LEGAL COUNSEL REPORTED PATIENT ALLEGATIONS OF PAIN IN BOTH HIPS IN 2008. SUBSEQUENTLY, PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF OSTEOLYSIS, ACETABULAR CYST, SYNOVITIS, METALLOSIS, DEGENERATED AND NECROTIC SYNOVIUM AND FOCAL FOREIGN BODY GIANT CELL REACTION. THE MODULAR HEAD, LINER, AND ACETABULAR CUP WERE REMOVED AND REPLACED. LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF METAL POISONING. 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) NOTES DATED (B)(6) 2004 REPORTS FEMORAL HEAD WEAR, EVIDENCE OF METAL AND POLY WEAR, FLUID IN CAPSULE, AND A FRACTURED AND FRAGMENTED ACETABULAR COMPONENT. THE CUP AND HEAD WERE REMOVED AND REPLACED. OP REPORT DATED (B)(6) 2014 NOTES PATIENT UNDERWENT A SECOND REVISION ON THE LEFT SIDE DUE TO PAIN, METALLOSIS, SUPRA-ACETABULAR CYST, AND SYNOVIAL FLUID. THE CUP AND HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301962 UNIV SOLID RNGLC SHL 46MM L22 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 493950

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R