BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA OPTION CERAMIC HEAD 36MM

    MDR report key: 18911428 · Received March 15, 2024

    Report

    Report Number
    3002806535-2024-00088
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    April 8, 2022
    Report Date
    April 19, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271397
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH, ITEM# 00625006530, LOT# J7181571 G7 LONGEVITY NEUTRAL 36MM E, ITEM# 20103605, LOT# 65255964 ECHO POR FMRL LAT NC, ITEM# 192111, LOT# 190070 G7 PPS LTD ACET SHELL 52E, ITEM# 010000663, LOT# 6881431 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 MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. IT IS EXPECTED THAT A WOUND HEALS IN STAGES AND SHOULD BE OF NORMAL APPEARANCE RELATED TO THE TIMEFRAME SINCE THE INCISION WAS MADE. A SURGICAL WOUND SHOULD BE WELL APPROXIMATED WITHOUT REDNESS, WARMTH, SWELLING AND/OR PURULENT DRAINAGE FOR THE DURATION OF ITS HEALING. THE EXPRESSION WOUND CONCERNS OR NON-HEALING WOUND WOULD IMPLY THAT THE APPEARANCE OF THE WOUND DEVIATES FROM WHAT A SURGICAL WOUND SHOULD APPEAR. IT MAY BE RED, HAVE DRAINAGE, ADDITIONAL PAIN, WARMTH AND SWELLING AS WELL AS HEALING TIME MAY BE DELAYED. THIS DEVIATION SIGNIFIES AN ALTERATION IN THE WOUND HEALING PROCESS WHICH CAN BE COMPLICATED BY PATIENT COMORBIDITIES SUCH AS DIABETES, OBESITY, SMOKING, AND OTHER CONDITIONS THAT ARE KNOWN TO SLOW A PERSON¿S ABILITY TO HEAL. WOUND COMPLICATIONS CAN BE TREATED CONSERVATIVELY OR WITH PROPHYLACTIC ORAL ANTIBIOTICS TO PREVENT FURTHER COMPLICATIONS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. UPDATED,

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY NEARLY TWO YEARS AGO AND SUBSEQUENTLY, APPROXIMATELY TWO WEEKS LATER, DEVELOPED ERYTHEMA AT THE MEDIAL ASPECT OF THE LEFT HIP INCISION AND WAS PRESCRIBED ORAL MEDICATION FOR TWO WEEKS AND WAS RESOLVED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472112 BIOLOX DELTA OPTION CERAMIC HEAD 36MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. N/A 3063479 00887868271397

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention