BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 28MM

    MDR report key: 15190756 · Received August 9, 2022

    Report

    Report Number
    3002806535-2022-00348
    Event Type
    Injury
    Date Received
    August 9, 2022
    Date of Event
    July 11, 2022
    Report Date
    September 29, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271373
    PMA / PMN Number
    K200959
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CAT# 110024465 LOT# 985900 G7 DUAL MOBILITY LINER 46MM G. CAT# 650-1067 LOT# 2900844 CER OPTION TYPE 1 TPR SLEVE. CAT# EP-200152 LOT# 038300 ACT ARTIC E1 HIP BRG 28X46MM S52 DIA28. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION.. D10 CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: G7 SCREW 6.5MM X 40MM. CATALOG NO.: 010001001. LOT NO.: 3559036. MEDICAL PRODUCT: G7 SCREW 6.5MM X 35MM. CATALOG NO.: 010001000. LOT NO.: 3916634. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED METAL TRANSFER ON OUTSIDE DIAMETER OF CERAMIC HEAD. DIMENSIONAL ANALYSIS OF THE PRODUCT DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS CONFORMING TO PRINT SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICE IS USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: IMAGES 2 AND 4 DEMONSTRATE SUPERIOR DISLOCATION OF THE FEMORAL COMPONENT WITH RESPECT TO THE ACETABULAR CUP. IMAGE 3 DEMONSTRATES ECCENTRIC POSITIONING OF THE FEMORAL HEAD COMPONENT WITHIN THE ACETABULAR CUP. IMAGE 1 DEMONSTRATES NORMAL ALIGNMENT OF THE FEMORAL COMPONENT WITHIN THE ACETABULAR CUP, LIKELY ACQUIRED IN THE IMMEDIATE POSTOPERATIVE STATE. DISLOCATION IS NONSPECIFIC BUT IS USUALLY PROCEEDED BY EXCESSIVE FORCE AND COULD BE RELATED TO TRAUMA. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO A DISLOCATION. THE HEAD AND LINER WERE REPLACED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941275 CER BIOLOXD OPTION HD 28MM PROSTHESIS, HIP, SEMI-CONSTRAINED LZO BIOMET UK LTD. N/A 2886422 00887868271373

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R