BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 36MM G

    MDR report key: 9161109 · Received October 7, 2019

    Report

    Report Number
    0001825034-2019-04465
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    June 24, 2019
    Report Date
    January 27, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 010000666- G7 PPS LTD ACET SHELL- 6007260, 51-104160- TPRLC 133 T1 PPS- 3844837, 11-363665- COCR MOD HD- 965310. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. THE PATIENT REPORTS WORSENED LEG LENGTH DISCREPANCY AFTER SURGERY REQUIRING ADJUSTMENT OF HIS SHOE LIFT TO ACCOMMODATE AMBULATION, PAIN, SWELLING AND HEMATOMA ABOUT 1 WEEK POST OP. HE RECEIVED AN INJECTION SHOT FOR PAIN 2 YEARS POST-OP. HE IS STILL EXPERIENCING PAIN AND HAS MUSCLE SPASMS IN THE LEFT LEG. HE HEARS CLICKING SOUNDS. HE HAS LOWER BACK PAIN. HE HAS SUFFERED FROM SCOLIOSIS SINCE HE WAS (B)(6). HE HAS ALSO HAD SEVERE HEADACHES FOR ABOUT 15 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTS WORSENED LEG LENGTH DISCREPANCY AFTER SURGERY REQUIRING ADJUSTMENT OF HIS SHOE LIFT TO ACCOMMODATE AMBULATION. HE FURTHER REPORTS HE IS STILL EXPERIENCING PAIN, MUSCLE SPASMS, AND CLICKING SOUNDS IN THE LEFT LEG. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# UNKNOWN, UNKNOWN STEM LOT# UNKNOWN. ITEM# UNKNOWN, UNKNOWN HEAD LOT# UNKNOWN. ITEM# UNKNOWN, UNKNOWN CUP LOT# UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCTS REMAIN IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 04464. 0001825034 - 2019 - 04467. 0001825034 - 2019 - 04469.

    Description of Event or Problem · 1

    WAS REPORTED THAT PATIENT RECEIVED INJECTION SHOT FOR PAIN ONE AND A HALF YEARS POST INITIAL RIGHT HIP ARTHROPLASTY. PATIENT REPORTS EXPERIENCING PAIN AND MUSCLE SPASMS IN THE LEFT LEG AND HEARS CLICKING SOUNDS. PATIENT ALSO REPORTS SEVERE HEADACHES FOR PAST 15 MONTHS. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE IF AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958455 G7 NEUTRAL E1 LINER 36MM G PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3959715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other