BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES

    MDR report key: 9446033 · Received December 10, 2019

    Report

    Report Number
    8030965-2019-70981
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    January 1, 2019
    Report Date
    November 22, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: INVESTIGATION SUMMARY THE COMPLAINT PROBLEM WAS NOT ABLE TO BE CONFIRMED BASED ON THE PROVIDED PICTURES, IT WAS WRITTEN IN THE COMPLAINT DESCRIPTION THAT "I HAVE SOME IMAGES OF THE INITIAL PLATING BUT NOT THE ACTUAL BROKEN PLATE AS THE PATIENT WAS OPERATED ON IN ANOTHER HOSPITAL POST PLATE BREAKING." THEREFORE THE COMPLAINT IS UNCONFIRMED. DEVICE HISTORY LOT PART: 02.124.421S LOT: L437009 MANUFACTURING SITE: MEZZOVICO RELEASE TO WAREHOUSE DATE: JUNE 16, 2017 EXPIRY DATE: JUNE 01, 2027 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: G4: DATE UPDATED. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. H3, H6: INVESTIGATION SUMMARY. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.,THE COMPLAINT PROBLEM WAS NOT ABLE TO BE CONFIRMED BASED ON THE PROVIDED PICTURES, IT WAS WRITTEN IN THE COMPLAINT DESCRIPTION THAT "I HAVE SOME IMAGES OF THE INITIAL PLATING BUT NOT THE ACTUAL BROKEN PLATE AS THE PATIENT WAS OPERATED ON IN ANOTHER HOSPITAL POST PLATE BRAKING." THEREFORE THE COMPLAINT IS UNCONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. D6: DATE OF IMPLANTATION IS AN UNKNOWN DATE IN (B)(6) 2019. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    CONCOMITANT DEVICES REPORTED: VARIABLE ANGLE (VA) LOCKING SCREW (PART # 02.231.285S, LOT # L844121, QUANTITY # 1), VA LOCKING SCREW (PART # 02.231.280S, LOT # 3L43052, QUANTITY # 1), VA LOCKING SCREW (PART # 02.231.255S, LOT # 1L93780, QUANTITY # 1), LOCKING SCREW SELF TAPPING (PART # 214.885S, LOT # L974385, QUANTITY # 1), VA LOCKING SCREW (PART # 02.231.275S, LOT # 2L57109, QUANTITY # 1), CONNECTION SCREW (PART # 02.120.605S, LOT # L567068, QUANTITY # 1), VA LOCKING SCREW (PART # 02.231.240S, LOT # 2L13089, QUANTITY # 1), VA LOCKING SCREW (PART # 02.231.285S, LOT # 1L82441, QUANTITY # 1), VA LOCKING SCREW (PART # 02.231.280S, LOT # 1L93767, QUANTITY # 1), VA LOCKING SCREW (PART # 02.231.265S, LOT # 2L77994, QUANTITY # 1), LOCKING ATTACHMENT PLATE (PART # 02.120.601S, LOT # 1L98249, QUANTITY # 1), VA LOCKING SCREW (PART # 02.231.238S, LOT # L664406, QUANTITY # 1), CORTEX SCREW SELF TAPPING (PART # 212.108S, LOT # 4L0085, QUANTITY # 1), HEADLESS COMPRESSION SCREW (PART # 212.107S, LOT # L485572, QUANTITY # 1), LOCKING SCREW (PART # 212.111S, LOT # 3L93822, QUANTITY # 1), LOCKING SCREW (PART # 212.104S, LOT # 3L53022, QUANTITY # 1), ), VA PERIPROSTHETIC LOCKING SCREW (PART # 02.231.018S, LOT # L380681, QUANTITY # 1), VA PERIPROSTHETIC LOCKING SCREW (PART # 02.231.018S, LOT # 7546147, QUANTITY # 1), VA LOCKING SCREW (PART # 02.231.246S, LOT # L517324, QUANTITY # 1).

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT REPORTED AS APPROXIMATELY (B)(6). DATE OF EVENT IS AN UNKNOWN DATE IN 2019. THIS REPORT IS FOR AN UNKNOWN PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: REPORTER IS A SYNTHES EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A VARIABLE ANGLE (VA) CONDYLAR PLATE WAS DISCOVERED TO BE BROKEN. THE PLATE BROKE APPROXIMATELY TWELVE (12) WEEKS AFTER IMPLANTATION. THE PATIENT HAD SUSTAINED A PERIPROSTHETIC FRACTURE OF THEIR HIP REPLACEMENT. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES: SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR AN UNKNOWN VA CONDYLAR PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238902 UNK - PLATES PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L437009

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention CONNECTION SCREW F/LOCKING ATTACHMENT PL| CORTSCR Ø4.5 SELF-TAP L85 SST| LOCKING ATTACHMENT PLATE 3.5 F/LCP 4.5/5| LOCKSCR Ø3.5 SELF-TAP L16 SST| LOCKSCR Ø3.5 SELF-TAP L22 SST| LOCKSCR Ø3.5 SELF-TAP L24 SST| LOCKSCR Ø3.5 SELF-TAP L30 SST| UNK - SCREWS: TRAUMA| UNK - SCREWS: TRAUMA| VA LOCKSCR Ø5 SELF-TAP L38 SST| VA LOCKSCR Ø5 SELF-TAP L40 SST| VA LOCKSCR Ø5 SELF-TAP L46 SST| VA LOCKSCR Ø5 SELF-TAP L55 SST| VA LOCKSCR Ø5 SELF-TAP L65 SST| VA LOCKSCR Ø5 SELF-TAP L75 SST| VA LOCKSCR Ø5 SELF-TAP L80 SST| VA LOCKSCR Ø5 SELF-TAP L80 SST| VA LOCKSCR Ø5 SELF-TAP L85 SST| VA PERIPROSTHETIC LOCK SCREW Ø5 SELF-TAP| VA PERIPROSTHETIC LOCK SCREW Ø5 SELF-TAP