BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL DORSAL ULNAR PLATE RIGHT 3 HOLES

    MDR report key: 8348479 · Received February 18, 2019

    Report

    Report Number
    0001822565-2019-00669
    Event Type
    Injury
    Date Received
    February 18, 2019
    Date of Event
    December 3, 2018
    Report Date
    March 11, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    K082078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED: D1, D2, D4, D10, D11, G5, H3, H4 MULTIPLE MDRS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED: 0001822565-2019-00669, 0001822565-2019-02388, 0001822565-2019-03835, 0002648920 -2019 - 00673, 0002648920 -2019 - 00674, 0001822565 -2019 - 03939, 0001822565 -2019 - 03940, 0001822565 -2019 - 03941, 0001822565 -2019 - 03942. D11, D4: ITEM #: ITEM NAME: LOT NUMBER: UNKNOWN PLATE, UNKNOWN, 47482804002, 2.7 MM LOCKING SCREW 40 MM LENGTH, LOT 61182393, DI#: (B)(4). 47235800903, PROXIMAL DORSAL ULNAR PLATE RIGHT 3 HOLES 77 MM LENGTH, LOT 62880435, DI#: (B)(4). 47234803235, CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 32 MM LENGTH, LOT 61168839, DI#: (B)(4). 47234803035, CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 30 MM LENGTH, LOT 62959292, DI#: (B)(4). 47235904438, 3.5 MM LOCKING SCREW WITH 2.7 MM HEAD 44 MM LENGTH, LOT 63068129, DI#: (B)(4). DI#: (B)(4). 47235902638, 3.5 MM LOCKING SCREW WITH 2.7 MM HEAD 26 MM LENGTH, LOT 61105234 DI#: (B)(4). 47482802202, 2.7 MM LOCKING SCREW 22 MM LENGTH, LOT 62545698, DI#: (B)(4). 47482802802, 2.7 MM LOCKING SCREW 28 MM LENGTH, LOT 62576438, DI#: (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. HOWEVER, THE PRODUCTS WERE RETURNED. VISUAL INSPECTION OF THE RETURNED PRODUCTS NOTED DISCOLORATION ON THE PLATE AND SCREWS (LN 61105234, 63068129). VARIOUS FOREIGN ELEMENTS LIKE C, O, NA, P, S, CL, AND CA WERE NOTED ON THE PLATE AND SCREW SAMPLES. THE FOREIGN ELEMENTS IDENTIFIED ARE PRESENT IN VARIOUS POTENTIAL CONTAMINANTS INCLUDING BIOLOGICAL SOFT TISSUE AND BONE, DRIED BIOLOGICAL FLUIDS (I.E. BLOOD), BONE CEMENT (CALCIUM-PHOSPHATE-BASED), CORROSION/METAL OXIDE PRODUCT OR VARIOUS DECONTAMINATION SOLUTIONS (I.E. HOSPITAL DETERGENTS). THEREFORE, THE SOURCE OF THESE FOREIGN ELEMENTS IS INCONCLUSIVE. SIGNS OF PITTING CORROSION OBSERVED WITHIN THE LOCKING THREADS ON BOTH THE LOCKING SCREW SAMPLES NO INDICATIONS OF PITTING CORROSION OBSERVED ON THE PROXIMAL DORSAL ULNAR PLATE SAMPLE. DISCOLORATION DEPOSITS IN THE LOCKING THREADS ON THE PLATE COULD HAVE OBSCURED THE EVIDENCE OF PITTING IF THERE WAS ANY. MATERIAL ANALYSIS ON THE DISCOLORATION FREE AREAS NOTED THE PRODUCT MATERIALS ARE CONFORMING TO THE SPECIFICATIONS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. NO DEVICE WAS RETURNED FOR EXAMINATION. REVIEW OF DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE NECESSARY PRODUCT/LOT CODE COMBINATION WAS NOT PROVIDED. ROOT CAUSE IS UNKNOWN. A BATCH EXAMINATION OF DEVICES RELATED TO THIS ISSUE WAS PERFORMED. FOLLOWING THE REMOVAL OF CONTAMINATION ON THE DEVICES, SCANNING ELECTRON MICROSCOPY IDENTIFIED ISOLATED PITTING CORROSION AT THE SCREW PLATE INTERFACE CONSTRAINED TO THE LOCKING THREADS OF THE PLATE AND THE SCREWS. THE ISOLATED PITTING WAS NOT IDENTIFIED IN OTHER LOCATIONS OF THE LOCKING PLATES AND SCREWS, INCLUDING THE DISCOLORED AREAS SURROUNDING THE HOLES FROM WHICH THE TISSUE DEPOSITS WERE REMOVED. THE ANALYSIS CONFIRMS THE DEVICE AND IT¿S MATERIALS ARE CONFORMING TO SPECIFICATIONS. ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. THE DEVICE LABELING STATES THAT IN-VIVO IMPLANT CORROSION IS A POSSIBLE ADVERSE EFFECT THAT MAY BE ANTICIPATED AS THE DEVICE IS IMPLANTED IN A CORROSIVE ENVIRONMENT. OCCURRENCE RATES ARE WITHIN THE EXPECTED RATES THEREFORE; NO FURTHER ACTION IS NEEDED AT THIS TIME. 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.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    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 INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE - FOREIGN - (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141986 PROXIMAL DORSAL ULNAR PLATE RIGHT 3 HOLES PLATE, FIXATION HRS ZIMMER BIOMET, INC. 62880435

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R SEE H10