BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX-DELTA MODULAR CERAMIC HEAD

    MDR report key: 6818359 · Received August 24, 2017

    Report

    Report Number
    0001825034-2017-06583
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    October 22, 2014
    Report Date
    June 27, 2019
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK061312
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: RANAWAT/BURSTEIN ACETABULAR SHELL, P/N 11-106054, L/N 085590; BIOLOX-DELTA MODULAR CERAMIC HEAD, P/N 12-115120, L/N 103360; E1 RINGLOC MAX-ROM ACETABULAR LINER; TAPERLOC, P/N 51-145090, L/N 299662. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-06582.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. INITIAL OP NOTES DATED (B)(6) 2014 WERE REVIEWED AND NO COMPLICATIONS WERE NOTED. REVISION OP NOTES DATED (B)(6) 2014 WERE REVIEWED AND IDENTIFIED PATIENT WAS REVISED DUE TO PAIN, SWELLING AND INFECTION. ALL THE COMPONENTS WERE REMOVED AND IMPLANTED WITH SPACERS. THE PATIENT WAS MARKED WITH ELEVATED LABS. EXTENDED TROCHANTERIC OSTEOTOMY PERFORMED DUE TO DIFFICULTY REMOVING THE FEMORAL STEM WITH FLEXIBLE OSTEOTOMES. DEPUY SPACES WERE IMPLANTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: 51-145090, TPRLC XR MP T1 PPS 9X102.5MM, LOT 2996622; EP-105994, EPOLY 36MM RLC LNR MROM SZ24, LOT 250530. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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 PATIENT RECEIVED A REVISION PROCEDURE ONE YEAR POST-IMPLANTATION DUE TO PAIN, COBALT AND CHROMIUM CORRODE, AND WEAR FROM THE SURFACES OF THE ACETABULAR CUP, FEMORAL HEAD, AND TAPER SLEEVE. POST-SURGICAL PATHOLOGY REPORTS INDICATED THAT THE ACETABULAR HEAD AND LINING WERE SURROUNDED BY FIBRO CONNECTIVE TISSUE AND BONE WITH NECROSIS, GRANULATION, ACUTE AND CHRONIC INFLAMMATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    PATIENT'S OPERATIVE REPORTS WERE RECEIVED WHICH REVEALED THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FOUR MONTHS POST-IMPLANTATION DUE TO PAIN, SWELLING, AND INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR ANTIBIOTIC CEMENT SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597628 BIOLOX-DELTA MODULAR CERAMIC HEAD PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 103360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R