BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP BA BIO 28MM 12/14 + 5

    MDR report key: 8960354 · Received September 4, 2019

    Report

    Report Number
    1818910-2019-103046
    Event Type
    Injury
    Date Received
    September 4, 2019
    Date of Event
    January 1, 2019
    Report Date
    August 14, 2019
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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: INVESTIGATION SUMMARY : FOLLOWING REVIEW OF THE INFORMATION RECEIVED, IT WAS CONCLUDED THAT IT WAS UNLIKELY THAT A POTENTIAL PRODUCT ISSUE WAS PRESENT. THE COMPLAINT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE REVIEWED AND FURTHER INVESTIGATION COMPLETED AS REQUIRED. FOLLOWING RECEIPT OF THE COMPLAINT PRODUCTS, THE COMPLAINT WAS TRANSFERRED TO BIOENGINEERING FOR INVESTIGATION. COMPLAINTS DATABASES SEARCHED THE HEAD, PRODUCT LOT 1111664 IDENTIFIED NO PREVIOUS COMPLAINTS. A REVIEW OF THE HEAD, PRODUCT LOT 1111664 MANUFACTURING RECORDS WAS COMPLETED BY THE MANUFACTURING SITE IN CORK, WITH NOTIFICATION RECEIVED THAT: ¿DHR REVIEW PRODUCT CODE 9111122, WORK ORDER 1111664 WAS MANUFACTURED ON 22/MAY/2003. 20 PARTS MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WAS NO NRS/CAPAS ASSOCIATED WITH THIS LOT. NO REPROCESSING ASSOCIATED WITH THIS LOT. NO SCRAP ASSOCIATED WITH THIS LOT. TWO DEVIATIONS FOUND. O DEVIATION (DEV-1601) IS ASSOCIATED WITH THIS LOT. THIS WAS OPENED TO ADD A LABEL TO CLOSE THE CARTON CLOSURE TAB. THIS IS NOT RELATED TO THE FAILURE MODE. O DEVIATION (DEV-1643) IS ASSOCIATED WITH THIS LOT. THIS WAS OPENED TO PLACE A WHITE SHIPPING LABEL ON THE BIOLOX FORTE PRODUCT THAT WAS BEING SHIPPED FOR IRRADIATION. THIS IS NOT RELATED TO THE FAILURE MODE. RAW MATERIAL COFC REVIEW: CERTIFICATE OF CONFORMANCE REVIEW FOR 4029623, PRODUCT CODE 9111122, WORK ORDER 1111664 MET SPECIFICATION.¿ IT WAS NOTED THAT THE PRODUCTS HAD AN EXPIRY DATE OF MAY-2008. (IFU REF. (B)(4). FOLLOWING INVESTIGATION BY BIOENGINEERING, A REPORT WAS RECEIVED, ADVISING: COMMENTS: THE CERAMIC HEAD DID NOT HAVE ANY SIGNIFICANT SIGNS OF DAMAGE. THE SECONDARY METAL TRANSFER ON THE HEAD TAPER APPEARED TYPICAL. ON THE POLY LINER, WEAR SCAR (POLISHED AREA) WAS OBSERVED, CLOSE TO THE EDGE OF THE BEARING SURFACE (IN THE AREA OF THE LIP). THE DEPTH OF THE WEAR SCAR WAS SIGNIFICANT RESULTING IN DEFORMATION OF THE BEARING SURFACE. NO SIGNS OF BACKSIDE WEAR OR DAMAGE TO THE LOCKING TAPER HAVE BEEN OBSERVED ON THE BACK OF THE LINER. THE LOCKING RING WAS DEFORMED - IT WAS NOT POSSIBLE TO DETERMINE WHETHER THIS HAD OCCURRED DURING THE REVISION SURGERY. NO SIGNS OF HEAD DISLOCATION WERE OBSERVED. IT WAS NOT POSSIBLE TO ATTRIBUTE ANY IMPLANT DAMAGE TO THE POLY LINER DISASSOCIATION FROM THE SHELL. THE COMPONENTS WERE IMPLANTED SINCE 2005. SUMMARY: FROM THE INFORMATION REVIEWED IT IS UNLIKELY THAT A POTENTIAL PRODUCT ISSUE WAS PRESENT. NO CORRECTIVE ACTION OR FURTHER INVESTIGATION IS RECOMMENDED. POST MARKET SURVEILLANCE IS PER SEP 419.¿ IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE HISTORY REVIEW :PRODUCT CODE 9111122, WORK ORDER 1111664 WAS MANUFACTURED ON 22/MAY/2003. 20 PARTS MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WAS NO NRS/CAPAS ASSOCIATED WITH THIS LOT.EXPIRY DATE OF MAY-2008. (IFU REF. (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    SURGEON IS ORDERING A PATIENT SPECIFIC DURALOC PE-INLAY RIGHT SIDE BECAUSE OF SUSPECTED LUXATION OF AN INLAY MADE OF PE OR CERAMIC. DATE OF INITIAL SURGERY: 2005, DATE OF PLANNED REVISION: NOT EARLIER THAN (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754899 HIP BA BIO 28MM 12/14 + 5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY INTERNATIONAL LTD - 8010379 1111664

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN HIP IMPLANT (LOCKING RING).