BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER 10 DEGREE ELEVATED RIM 22

    MDR report key: 12868626 · Received November 24, 2021

    Report

    Report Number
    0001822565-2021-03311
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    May 29, 2020
    Report Date
    December 16, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K990135
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D1, D2, D4, G3, G4, H1, H2, H4, H10. D10: CATALOG NUMBER: 00631004022 LOT NUMBER: 63254391 BRAND: XLPE LINERS. CATALOG NUMBER :00786400900 LOT NUMBER:63456639 BRAND: FEMORAL STEM. CATALOG NUMBER : 01.00561.314 LOT NUMBER:2936141 BRAND: WAGN CONE PROSTHESIS. CATALOG NUMBER: 00801802230 LOT NUMBER: 63452825 BRAND: COCR HEADS. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT 0002648920-2021-00406. 0001822565-2021-03311. 0001822565-2021-03565.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: A LEFT THA WAS PERFORMED DUE TO OA AND HIP DYSPLASIA. A REVISION OCCURRED AS A DISLOCATION OCCURRED. THE ACETABULUM WAS FOUND WELL FIXED. THE HEAD AND STEM WERE EXPLANTED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. PER THE FOLLOW UP INFORMATION, THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO THE PATIENT FAILING TO FOLLOW MEDICAL ADVICE AND PARTICIPATING IN ACTIVITIES THAT CAUSED THEIR HIP TO DISLOCATE AND THE STEM TO LOOSEN. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). SOURCE: (B)(6). CONCOMITANT MEDICAL DEVICES: CATALOG NUMBER :00801802230 LOT NUMBER:63452825 BRAND: FEMORAL HEAD; CATALOG NUMBER :00786400900 LOT NUMBER:63456639 BRAND: FEMORAL STEM; CATALOG NUMBER : 01.00561.314 LOT NUMBER:2936141 BRAND: WAGN CONE PROSTHESIS. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT 0002648920-2021-00406. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND DISLOCATION APPROXIMATELY 17 DAYS POST IMPLANTATION. DURING THE REVISION, THE FEMORAL STEM WAS FOUND LOOSE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND DISLOCATION APPROXIMATELY 17 DAYS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769167 LINER 10 DEGREE ELEVATED RIM 22 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 63254391
    1769168 LINER 10 DEGREE ELEVATED RIM 22 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 63254391

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention| H SEE H10 NARRATIVE