BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR INSERT, MODULAR¸ 42/28

    MDR report key: 17162804 · Received June 20, 2023

    Report

    Report Number
    0009613350-2023-00313
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 20, 2023
    Report Date
    August 17, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LPH
    UDI-DI
    00889024503946
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM#14280620; LOT#3150216; COCR HEAD 28/ 0 'M' 12/14. ITEM#61270044; LOT#3150272; BIPOLAR SHELL, MODULAR¸ 44. G2- GERMANY. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-0322.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00322-1 UPON FURTHER ASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED AS THE REPORTED PRODUCTS ARE NOT THE PART OF COMPLAINT. IMPLANTATION REPORTS PROVE THAT IMPLANTS LISTED IN BFARM CASE (B)(4) WERE USED IN REVISION SURGERY FOR THE PATIENT FROM BFARM CASE (B)(4) (MDR REPORTS 0009613350-2023-00324 AND 0009613350-2023-00325). AFTER REVISION SURGERY, NO COMPLICATIONS WERE REPORTED. GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT THE IMPLANTATION WITH HIP PROSTHESES. POSTOPERATIVELY, DURING THE EXERCISE, A DECOUPLING OF THE HEAD AND INLAY OCCURRED WITH DISLOCATION OF THE HIP. REVISION SURGERY WAS PERFORMED FOR A DISLOCATED HIP. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    UPON FURTHER ASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED AS THE REPORTED PRODUCTS ARE NOT THE PART OF COMPLAINT. IMPLANTATION REPORTS PROVE THAT IMPLANTS LISTED IN BFARM CASE (B)(4) WERE USED IN REVISION SURGERY FOR THE PATIENT FROM BFARM CASE (B)(4) (MDR REPORTS 0009613350-2023-00324 AND 0009613350-2023-00325). AFTER REVISION SURGERY, NO COMPLICATIONS WERE REPORTED. GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545706 BIPOLAR INSERT, MODULAR¸ 42/28 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3150656 00889024503946

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H SEE H10 NARRATIVE.