BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 28/0MM T1

    MDR report key: 10565320 · Received September 22, 2020

    Report

    Report Number
    3002806535-2020-00420
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    August 25, 2020
    Report Date
    September 30, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    K131684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: MEDICAL PRODUCT: TPRLC XR MP FP T1 PPS 5X95MM, CATALOG #: 51-149050, LOT #: 6314874. MEDICAL PRODUCT: ACT ARTIC E1 HIP BRG28X38MM, CATALOG #: EP-200144, LOT #: 315330. MEDICAL PRODUCT: G7 PPS LTD ACETABULAR SHL 48C, CATALOG #: 010000661, LOT #: 6263144. MEDICAL PRODUCT: G7 DUAL MOBILITY LINER 38MM C, CATALOG #: 110024461, LOT #: 385370. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEM 650-1158. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THIS ITEM AND LOT COMBINATION. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: KNOWN INHERENT RISK. REVIEW OF THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABELING, AND THE RISK MANAGEMENT FILE, DETERMINED THAT THE REPORTED EVENT IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF THE DEVICE. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, A REVISION SURGERY WAS PERFORMED DUE TO PAIN ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL DEVICES: MEDICAL PRODUCT: TPRLC XR MP FP T1 PPS 5X95MM, CATALOG #: 51-149050, LOT #: 6314874; MEDICAL PRODUCT: ACT ARTIC E1 HIP BRG28X38MM, CATALOG #: EP-200144, LOT #: 315330; MEDICAL PRODUCT: G7 PPS LTD ACETABULAR SHL 48C, CATALOG #: 010000661, LOT #: 6263144. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, A REVISION SURGERY WAS PERFORMED DUE TO PAIN ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031269 DELTA CER FEM HD 28/0MM T1 CERAMIC FEMORAL HEAD PROSTHESIS LPH BIOMET UK LTD. N/A 2018092315

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R