BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEU +5MM E1 LINER 36MM F

    MDR report key: 12432254 · Received September 7, 2021

    Report

    Report Number
    0001825034-2020-04306
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    October 21, 2020
    Report Date
    December 9, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304673519
    PMA / PMN Number
    K142882
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110010265  G7 MULTIHOLE CUP - 3863830. 010000997  G7 SCREW  3865243. 010000997  G7 SCREW  3847793. 010000997  G7 SCREW  3874188. 010000997  G7 SCREW  3855555. 010000999  G7 SCREW  3871319. 010001001  G7 SCREW  3855562. 00786401220  TM PRIMARY STEM  61209287. 00877703603  BIOLOX DELTA HEAD  2790040. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING THE PATIENT VISITING THE ER FOR DISLOCATIONS THAT SPONTANEOUSLY REDUCED AND IS NOW HAVING PAIN AND SWELLING. DURING FIRST STAGE REVISION, CT SCAN SHOWED TRACKING WOUND INTO JOINT SPACE REPRESENTING AN INFECTION OF UNKNOWN AGE. LARGE ABSCESS WAS FOUND ALONG WITH FIBRINOUS DEBRIS. FEMORAL COMPONENT LACK OF GROWTH IN CERTAIN AREAS AND ABSCESS TRACKED TO FEMORAL COMPONENT AS WELL. OSTEOTOMY PERFORMED TO REMOVE STEM. INFECTION WAS NOTED TO HAVE BEEN CAUSE OF AREAS OF NON-GROWTH. PATIENT RETURNED FOR A SECOND FIRST STAGE REVISION DUE TO CONTINUED INFECTION. PRIOR CULTURES NEGATIVE, TREATED INFECTION WITH IV ANTIBIOTIC THERAPY, MAKERS HAD RETURNED TO NORMAL, BUT NOW INCREASE AND CONCERN FOR SEPSIS, CLOUDY DRAINAGE FROM LATERAL SIDE OF INCISION. EXCISED NON-HEALING PORTION OF WOULD THAT PRESENTED WITH ACTIVE DRAINAGE. WIRES WERE PLACED TO STABILE FEMUR AND NEW ANTIBIOTIC DEVICE IMPLANTED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS UNABLE TO BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-04304.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO PAIN AND METAL RELATED PATHOLOGY APPROXIMATELY 7 YEARS POST IMPLANTATION. SUBSEQUENTLY, THE PATIENT VISITED THE EMERGENCY ROOM DUE TO DISLOCATIONS, PAIN AND SWELLING WITH NO NOTED MEDICAL INTERVENTION. THE PATIENT THEN UNDERWENT A SECOND REVISION APPROXIMATELY 4 YEARS LATER DUE TO CHRONIC INFECTION. ALL DEVICES WERE REMOVED AND REPLACED WITH SPACERS. APPROXIMATELY 1 MONTH LATER THE PATIENT STILL HAD ONGOING INFECTION DESPITE USE OF ANTIBIOTICS, SO NEW SPACERS WERE IMPLANTED ALONG WITH WIRES. THERE IS NO REPORT OR NEW PERMANENT IMPLANTS BEING IMPLANTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333553 G7 NEU +5MM E1 LINER 36MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 3579795 00880304673519

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10