BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 5CM DIAPHYSEAL SEGMENT

    MDR report key: 10511967 · Received September 9, 2020

    Report

    Report Number
    0001825034-2020-03478
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    August 28, 2020
    Report Date
    January 22, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304238824
    PMA / PMN Number
    K123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G4, G5, G7, H1, H2, H3, H6, AND H10. VISUAL EXAMINATION OF THE RETURNED PRODUCT FOUND SIGNS OF BEING IMPLANTED (SCRATCHES AND FOREIGN MATERIAL). MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: D11. D11- MEDICAL PRODUCT. OSS 7CM SEGMENTAL FEMORAL RT, ITEM# 150354, LOT# 804700. THE PRODUCT THAT IS BEING REPORTED HAS BEEN CHANGED FROM THE OSS 7CM SEGMENTAL FEMORAL RT TO OSS 5CM DIAPHYSEAL SEGMENT AS THAT IS ACTUALLY THE PRODUCT ASSOCIATED WITH THE FEMORAL LOOSENING.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11- MEDICAL PRODUCT OSS CEMENTED IM STEM 15X150 , ITEM# 150369 , LOT# 613330, OSS 5CM DIAPHYSEAL SEGMENT ,ITEM# 150465 LOT# 925300, OSS POLY FEMORAL BUSHINGS, ITEM# 150477 LOT# 742240, OSS TIBIAL POLY BEARING 14MM, ITEM# 150411 LOT# 560730, OSS POLY TIBIAL BUSHING , ITEM# 150476 LOT# 315070, OSS POLY LOCK PIN, ITEM# 150478 LOT# 668620, OSS POLY FEMORAL BUSHINGS, ITEM# 150477 LOT# 742240, OSS AXLE , ITEM# 150480, LOT# ,258450, OSS REINFORCED YOKE, ITEM# 150493, LOT# 061560, OPTIP 60 REFOB PLUS BONE CMT-3 ITEM# 4721502084-3 LOT# 807BA06965

    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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2020-03479. MEDICAL PRODUCT: OSS CEMENTED IM STEM 15X150 ITEM# 150369 LOT# 613330. OSS 5CM DIAPHYSEAL SEGMENT ITEM# 150465 LOT# 925300. OSS POLY FEMORAL BUSHINGS ITEM# 150477 LOT# 742240. OSS TIBIAL POLY BEARING 14MM ITEM# 150411 LOT# 560730. FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR AND SEVEN MONTHS¿ POST IMPLANTATION DUE TO EARLY ASEPTIC LOOSENING OF THE FEMORAL STEM. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970984 OSS 5CM DIAPHYSEAL SEGMENT PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 925300 00880304238824

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R SEE H10.| SEE H10.| SEE H10.