BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEAD 28/-4 S 12/14

    MDR report key: 17162820 · Received June 20, 2023

    Report

    Report Number
    0009613350-2023-00325
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 14, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LPH
    UDI-DI
    00889024393776
    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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00324-1. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE DEVICES HAVE NOT BEEN RETURNED FOR EXAMINATION DUE TO MISSING PATIENT CONSENT. THEREFORE, NO DEVICE EXAMINATION COULD BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. IN TOTAL THREE UNDATED RADIOGRAPHS WERE PROVIDE, CONSISTING OF ONE AP PELVIS AND TWO AP VIEWS OF THE RIGHT HIP, WERE RECEIVED AND EVALUATED BY A HEALTH CARE PROFESSIONAL (RADIOLOGIST). THE ASSESSMENT IDENTIFIED A DISLOCATION OF THE RIGHT HIP ARTHROPLASTY WITH DISPLACEMENT OF THE ACETABULAR IMPLANT. THE PROSTHETIC FEMORAL HEAD IS SEATED WITHIN THE NATIVE ACETABULAR FOSSA. THERE IS NO FRACTURE. THE BONE QUALITY APPEARS OSTEOPENIC. WITH THE AVAILABLE INFORMATION, THE REPORTED DISLOCATION CAN BE CONFIRMED; NEVERTHELESS, 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.

    Additional Manufacturer Narrative · 0

    (B)(4).. D10: ITEM#61272842; LOT#3146967; BIPOLAR INSERT, MODULAR, 42/28. ITEM#4710500394-3; LOT#AX44CH0111; OPTIPAC 40 REFOB BONE CMT R-3. ITEM#0106010003; LOT#3123522; AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 3, TAPER 12/14. ITEM#61270044; LOT#3145111; 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 - 00324.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT IMPLANTATION WITH HIP PROSTHESES. POSTOPERATIVELY, DURING THE EXERCISE, A DECOUPLING OF HEAD AND INLAY OCCURRED WITH DISLOCATION OF THE HIP. THIS RESULTED IN REVISION SURGERY BEING PERFORMED SIX (6) DAYS AFTER THE INITIAL PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546494 COCR HEAD 28/-4 S 12/14 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3148072 00889024393776

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H