BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 NEUTRAL E1 LINER 32MM F

    MDR report key: 8934395 · Received August 27, 2019

    Report

    Report Number
    0001825034-2019-03757
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Date of Event
    August 7, 2019
    Report Date
    May 11, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, D10, G3, G4, G7, H1, H2, H3, H10 G3; FOREIGN REPORT SOURCE: JAPAN A G7 NEUTRAL E1 LINER 32MM F, PART # 010000850 FROM LOT 3841534, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE BARB TO BE ROUGHENED SUCH THAT A POLY STRAND PROTRUDES FROM THE LINER. THE BARB IS NICKED IN ANOTHER LOCATION. THE OUTER RADIUS EXHIBITS A SCRATCH NEAR THE SCREW HOLE IN THE LINER. SCRATCHING WAS ALSO OBSERVED ON THE LINER'S RIM. NO DIMENSIONAL ANALYSIS WILL BE CONDUCTED AT THIS TIME DUE TO THE ATTEMPTS TO IMPLANT AND REMOVE THE DEVICE. 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

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #: UNKNOWN UNKNOWN HEAD LOT #: UNKNOWN; ITEM #: UNKNOWN UNKNOWN STEM LOT #: UNKNOWN; 010000850 G7 NEUTRAL E1 LINER 32MM F 6074805; 110010245 G7 OSSEOTI 4 HOLE SHELL 54MM F 6416552. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2019-03758 LINER 2; 0001825034-2019-03760 CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO G7 E1 LINERS WOULD NOT ASSEMBLE WITH G7 ACETABULAR SHELL. SURGERY WAS FINISHED WITH BACKUP PRODUCT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731798 G7 NEUTRAL E1 LINER 32MM F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3841534

    Patients

    Seq Age Sex Outcome Treatment
    1