BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW SELF-TAPPING 35 MM LENGTH 6.5 MM DIA.

    MDR report key: 6885888 · Received September 22, 2017

    Report

    Report Number
    0002648920-2017-00561
    Event Type
    Injury
    Date Received
    September 22, 2017
    Date of Event
    October 23, 2017
    Report Date
    February 15, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    PK840643
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00662406525, BONE SCREW SELF-TAPPING 25 MM LENGTH 6.5 MM DIA, 63436751; 00662406530, BONE SCREW SELF-TAPPING 30 MM LENGTH 6.5 MM DIA, 63517725; 00662406535, BONE SCREW SELF-TAPPING 35 MM LENGTH 6.5 MM DIA, 63517727; 00489405420, ACETABULAR REVISION SYSTEM, 63271869; 00877702804, BIOLOX® OPTION HEAD XL, 2844958; PART: 110024464 NAME: G7 DUAL MOBILITY LINER 44MM F LOT: 924650; PART: EP-200150 NAME: ACT ARTIC E1 HIP BRG 28X44MM, LOT: 802000; PART: 010000996 NAME: G7 SCREW 6.5MM X 15MM LOT: 3741173; PART: 010000996 NAME: G7 SCREW 6.5MM X 15MM, LOT: 3805567; PART: 010000997 NAME: G7 SCREW 6.5MM X 20MM LOT: 3666651; PART: 010000997 NAME: G7 SCREW 6.5MM X, 20MM LOT: 3974192; PART: 010001000 NAME: G7 SCREW 6.5MM X 35MM LOT: 3970984; PART 00489405420 TRABECULAR METAL¿¢ ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT LOT # 63271869; PART: 010000999 NAME:G7 SCREW 6.5MM X 30MM LOT: 3914370. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE STERILIZATION CERTIFICATE FOR THE DEVICE IDENTIFIED NO ANOMALIES. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. COMPATIBILITY CHECK OF THE REPORTED PRODUCTS IDENTIFIED NO ISSUES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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: 0002648920 - 2017 - 00560, 0002648920 - 2017 - 00562, 0002648920 - 2017 - 00563, 0002648920-2017-00695.

    Additional Manufacturer Narrative · 1

    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 · 1

    UDI: (B)(4). 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 · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT 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. CONCOMITANT MEDICAL PRODUCTS: 00662406525, BONE SCREW SELF-TAPPING 25 MM LENGTH 6.5 MM DIA, 63436751; 00662406530, BONE SCREW SELF-TAPPING 30 MM LENGTH 6.5 MM DIA, 63517725; 00662406535, BONE SCREW SELF-TAPPING 35 MM LENGTH 6.5 MM DIA, 63517727; 00489405420, ACETABULAR REVISION SYSTEM, 63271869; 00877702804, BIOLOX® OPTION HEAD XL, 2844958. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920 - 2017 - 00560, 0002648920 - 2017 - 00562, 0002648920 - 2017 - 00563.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY TWO (2) MONTHS POST-OPERATIVELY DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS BEEN INDICATED FOR A REVISION SURGERY DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668111 BONE SCREW SELF-TAPPING 35 MM LENGTH 6.5 MM DIA. PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 63204312

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R