BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA OPTION CERAMIC HEAD 28MM HEAD DIAMETER

    MDR report key: 6158020 · Received December 9, 2016

    Report

    Report Number
    0001825034-2016-05143
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    March 22, 2016
    Report Date
    June 23, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-05142 / 05143 / 05144).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. CONCOMITANT PRODUCT: ACTIVE ARTICULATING LINER ARCOM XL 28 X 44 MM, CATALOG# XL-200150, LOT# 734990. CERAMIC OPTION TYPE 1 TAPER SLEEVE 0 MM, CATALOG# 650-1066, LOT# 485520. TAPERLOC LATERAL STEM PC 11 MM T1, CATALOG# 11-103205, LOT# 817390. M2A-MAGNUM PF CUP PF CUP 50ODX44ID, CATALOG# US157850, LOT# 435130. DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A PRODUCT EVALUATION COULD NOT BE CONDUCTED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. IN REVISION NOTES FOR PRIOR COMPLICATION TREATMENT WHERE AN ARTICULATING LINER AND HEAD WERE REVISED, PREOPERATIVE EVALUATION FOR INFECTION WAS NEGATIVE; SYNOVIAL FLUID FROM THE PSEUDOCAPSULE WAS ALSO NEGATIVE FOR ACUTE INFLAMMATION CHECK. STEM AND CUP STABILITY WERE ASSESSED WITHOUT ANY ISSUE DURING THIS PRIOR PROCEDURE. DURING STAGE ONE REVISION DUE TO INFECTION, THE CUP AND STEM WERE REMOVED WITHOUT SIGNIFICANT BONE LOSS. THERE WAS SIGNIFICANT BONE LOSS IN THE INFERIOR PORTION OF HER ACETABULUM FROM PREVIOUS SURGERY; HOWEVER, ISCHIUM, ANTERIOR AND POSTERIOR WALL AND DOME ARE INTACT. INFLAMED AND NECROTIC SOFT TISSUE WERE DEBRIDED. AFTER STAGE ONE TREATMENT, INFECTION PERSISTED. IN REVISION NOTES STAGE TWO, AGGRESSIVE DEBRIDEMENT PERFORMED. ROOT CAUSE WAS UNDETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY REPLACEMENT DUE TO FEVER, TACHYCARDIA, LEFT HIP DRAINAGE AND INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TWO-STAGE HIP ARTHROPLASTY REVISION DUE TO FEVER, TACHYCARDIA, LEFT HIP DRAINAGE AND INFECTION. THE FIRST STAGE PROCEDURE TOOK PLACE ON (B)(6) 2016 AND SECOND STAGE PROCEDURE TOOK PLACE ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808508 BIOLOX DELTA OPTION CERAMIC HEAD 28MM HEAD DIAMETER PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 785790

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R