BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE M 36MM +5

    MDR report key: 1772329 · Received July 23, 2010

    Report

    Report Number
    1818910-2010-05349
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 25, 2010
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. A REVIEW OF THE DEVISE HISTORY REPORT DID NOT REVEAL ANY ANOMALIES REGARDING THE REPORTED EVENT AGAINST THE PRODUCT AND LOT COMBINATION. FOLLOWING INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: CONCLUSION: PATIENT (B)(6), HEIGHT, WEIGHT AND ACTIVITY UNKNOWN. IMPLANTED FOR 5 YEARS. (B)(4). CUP IMPLANTED AT APPROXIMATELY (B)(4) WITH VERY LITTLE VERSION ACCORDING TO X-RAY; (B)(4) REPORTS INDICATES CUP ANGLE AT 68 WITH 3 RETROVERSION (CT ANALYSIS). ESR RESULT SHOWS NORMAL LEVELS, CRP LEVEL IS ELEVATED INDICATIVE OF INFECTION, HOWEVER NO MICROBES COULD BE GROWN AND THE PATIENT IS DESCRIBED AS FIT AND WELL (NO TEMPERATURE) SUGGESTING THERE WAS NO INFECTION, RATHER AN INFLAMMATORY RESPONSE. BLOOD ION LEVELS ARE NOT ELEVATED CONSIDERING THE HIGH LEVEL OF WEAR THAT HAS OCCURRED. THE LINEAR WEAR RATE OF THE HEAD WAS (B)(4)/YEAR; THE CUP SAW (B)(4)/YEAR OF EDGE WEAR (LIKELY DUE TO THE STEEP CUP ANGLE). LEG LENGTH ALSO APPEARS SLIGHTLY LENGTHENED COMPARED TO THE CONTRALATERAL (ALSO REPLACED). FROM THE (B)(4) REPORT PHOTOS THE HEAD APPEARS TO BE VERY SCRATCHED, LIKELY AS A RESULT OF THE HIGH CUP ANGLE. THE PHOTO OF THE CUP DOES NOT SHOW MUCH DAMAGE, HOWEVER DUE TO THE HIGH IMPLANTATION ANGLE THIS IS LIKELY TO BE HIDDEN AROUND THE RIM. PHOTO IMAGES OF SCRATCHES ARE, HOWEVER, EXTREMELY MISLEADING. THE HIGH CUP ANGLE AND ELEVATED CRP LEVEL WILL HAVE BOTH HAVE BEEN LIKELY CONTRIBUTORS TO PAIN AND DISCOMFORT. THE COMPLAINT SHALL BE CLOSED WITH AN UNJUSTIFIED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED; THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND / OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE DEVISES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. A REVIEW OF THE DEVISE HISTORY REPORT DID NOT REVEAL ANY ANOMALIES REGARDING THE REPORTED EVENT AGAINST THE PRODUCT AND LOT COMBINATION. FOLLOWING INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: CONCLUSION: PATIENT AGED (B)(6), HEIGHT, WEIGHT, AND ACTIVITY UNKNOWN. IMPLANTED FOR 5 YEARS. LIRC REPORT. CUP IMPLANTED AT APPROXIMATELY 68??5? WITH VERY LITTLE VERSION ACCORDING TO X-RAY; LIRC REPORTS INDICATES CUP ANGLE AT 68? WITH 3? RETROVERSION (CT ANALYSIS). ESR RESULT SHOWS NORMAL LEVELS, CRP LEVEL IS ELEVATED INDICATIVE OF INFECTION, HOWEVER NO MICROBES COULD BE GROWN AND THE PATIENT IS DESCRIBED AS FIT AND WELL (NO TEMPERATURE) SUGGESTING THERE WAS NO INFECTION, RATHER AN INFLAMMATORY RESPONSE. BLOOD ION LEVELS ARE NOT ELEVATED CONSIDERING THE HIGH LEVEL OF WEAR THAT HAS OCCURRED. THE LINEAR WEAR RATE OF THE HEAD WAS 53.4?M/YEAR; THE CUP SAW 73.05?M/YEAR OF EDGE WEAR (LIKELY DUE TO THE STEEP CUP ANGLE). LEG LENGTH ALSO APPEARS SLIGHTLY LENGTHENED COMPARED TO THE CONTRALATERAL (ALSO REPLACED). FROM THE LIRC REPORT PHOTOS THE HEAD APPEARS TO BE VERY SCRATCHED, LIKELY AS A RESULT OF THE HIGH CUP ANGLE. THE PHOTO OF THE CUP DOES NOT SHOW MUCH DAMAGE, HOWEVER DUE TO THE HIGH IMPLANTATION ANGLE THIS IS LIKELY TO BE HIDDEN AROUND THE RIM. PHOTO IMAGES OF SCRATCHES ARE, HOWEVER, EXTREMELY MISLEADING. THE HIGH CUP ANGLE AND ELEVATED CRP LEVEL WILL HAVE BOTH HAVE BEEN LIKELY CONTRIBUTORS TO PAIN AND DISCOMFORT. THE COMPLAINT SHALL BE CLOSED WITH AN UNJUSTIFIED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED; THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND / OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    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). INVESTIGATION SUMMARY: THE COMPLAINT, ORIGINALLY DINT 13969, WAS RE-OPENED UPON RECEIVING FURTHER INFORMATION FROM (B)(6)' S WHICH WAS: UPDATE AD 10 JAN 2018: ADDITIONAL INFORMATION RECEIVED. ADDED IP FOR CORAIL STEM, PATIENT'S NAME AND PRODUCT/LOT DETAIL FOR PINNACLE METAL INSERT. NO PRODUCTS WERE EVER RETURNED, ALTHOUGH PATIENTS RECORDS WERE ORIGINALLY RETURNED AND FULLY EVALUATED, THE RESULTS OF WHICH WERE DOCUMENTED IN (B)(4). A COPY OF WHICH CAN BE FOUND ATTACHED IN THIS COMPLAINT IN THE NOTES AND ATTACHMENT SECTION. THIS INVESTIGATION IS ONLY REVIEWING THE NEW INFORMATION THAT HAS SINCE BEEN PROVIDED. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. 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

    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

    PATIENT WAS REVISED DUE TO PAIN, SQUEAKING, AND HIGH LEVEL OF METAL IONS.

    Description of Event or Problem · 1

    UNEXPLAINED PAIN, SQUEAKING, HIGH METAL IONS. PATIENT FUNCTION IMPAIRED, PRIOR TO REVISION FIT AND WELL LT THR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICUL/EZE M 36MM +5 87JDI; 87LPH JDI DEPUY INTERNATIONAL LTD - 8010379 NA 1823104

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention