BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULOX HEAD, M, A, 28/0, TAPER 12/14

    MDR report key: 6851173 · Received September 8, 2017

    Report

    Report Number
    0009613350-2017-01189
    Event Type
    Injury
    Date Received
    September 8, 2017
    Date of Event
    August 6, 2017
    Report Date
    February 13, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCTS, ZIMMER BIOMET: ALLOCLASSIC, CSF INSERT, 61/28, REF# 3505, LOT#: 2841954. ALLOCLASSIC, CSF SHELL, UNCEMENTED, 61, REF# 3535, LOT# 2840044. ALLOCLASSIC, SL STEM, UNCEMENTED, 2, TAPER 12/14, REF# 2842, LOT# 2851481. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: REVISION SURGERY DUE TO BREAKAGE. A TREND IS IDENTIFIED IF AT LEAST ONE OF THE FOLLOWING CRITERIA IS MET: 3 SIMILAR EVENTS WITHIN 1 MONTH FOR THE SAME ITEM NUMBER. 6 SIMILAR EVENTS WITHIN 6 MONTHS FOR THE SAME ITEM NUMBER. 2 SIMILAR EVENTS FOR THE SAME LOT NUMBER. REVIEW OF EVENT DESCRIPTION: ACCORDING TO THE INFORMATION AT THE HAND, PATIENT RECEIVED SULOX HEAD ON (B)(6) 2016 ON UNKNOWN HIP SIDE AND UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO HEAD BREAKAGE. REVIEW OF RECEIVED DATA: REVISION SURGERY REPORT DATED (B)(6) 2017 WAS REVIEWED. PATIENT UNDERWENT REVISION SURGERY AND BROKEN HEAD WAS REVISED. NEW HEAD AND INSERT WERE PLACED. IMPLANT STICKERS OF SULOX HEAD, ALLOCLASSIC CSF INSERT, ALLOCLASSIC CSF SHELL AND ALLOCLASSIC SL STEM WERE RECEIVED. DEVICES ANALYSIS: VISUAL EXAMINATION: CERAMIC HEAD: THE LASER ENGRAVING ON THE FEMORAL HEADS IS AS SHOWN BELOW, WHERE ZZ IS THE YEAR OF FABRICATION AND YYYYY IS THE SERIAL NUMBER. 28M/O 12/14 ZZ A S YYYW ISO 6474 THE LASER ENGRAVING ON THE RECEIVED FRACTURED FEMORAL HEAD READS AS FOLLOWS: 28M/O 12/14 15 A S 19123 ISO 6474 THE FRACTURED BALL HEAD COULD BE CLEARLY IDENTIFIED BASED ON THE LASER ENGRAVING OF THE SERIAL NUMBER AND THE YEAR OF FABRICATION. FOUR LARGE FRAGMENTS WERE RECEIVED. 5. 8 % OF THE IMPLANT VOLUME IS MISSING. INSPECTION OF THE CONE SURFACE AND BOTTOM: FRAGMENTS 1, 2, 3 AND 4 SHOW BOTH PRIMARY AS WELL AS SECONDARY METAL TRANSFER. NO TRACES OF BLOOD WERE FOUND ON THE FRAGMENTS. A TOTAL NUMBER OF THREE SMALL FRAGMENTS WAS DELIVERED AS WELL,. INSPECTION OF THE FRACTURE SURFACES: SECONDARY METAL TRANSFER IS ESPECIALLY VISIBLE ON THE FRACTURE SURFACES OF FRAGMENTS 1 AND 4, FRAGMENTS 1 AND 4 SHOW ONLY MINOR SECONDARY METAL TRANSFER. INSPECTION OF THE ARTICULATING SURFACE: METAL TRANSFER IS VISIBLE ON FRAGMENT 4. DETERMINATION OF MATERIAL PROPERTIES: THE DENSITY OF ALL LARGE FRAGMENTS IS MEASURED TO BE MORE THAN OR EQUAL TO 3.98 G/CM3, THE SPECIFIED VALUE IN THE SPECIFICATIONS IS MORE THAN OR EQUAL TO 3.96 G/CM3. IN THE CASE OF A SYMMETRICAL TAPER FIT SITUATION BETWEEN THE CERAMIC BALL HEAD AND THE METALLIC STEM TAPER, THIN CONCENTRIC LINES (PRIMARY METAL TRANSFER) OVER THE WHOLE CIRCUMFERENCE OF THE TOP TAPER ZONE ARE EXPECTED. THESE PRIMARY METAL TRANSFER PATTERNS CAN BE FOUND WITH VARYING INTENSITY ON THE CONICAL BORE SURFACE. MOREOVER, ON THE LOWER AND MIDDLE CONICAL ZONE METAL TRANSFER LOCALIZED ON A PARTICULAR SIDE, ESPECIALLY VISIBLE ON FRAGMENT 1, IS VISIBLE. THOSE FEATURES ARE ASSUMED TO BE POSSIBLE INDICATORS OF A MISALIGNMENT OF HEAD ON THE STEM DURING/POST SURGERY. PE INSERT: THE INSERT IS SIGNIFICANTLY DEFORMED. THE ARTICULATING SURFACE IS WORN EXCESSIVELY. METAL TRANSFER CAN BE OBSERVED IN THE DENTS. THIS WEAR IS ASSUMED TO BE DUE TO CONTACT BETWEEN THE METALLIC STEM TAPER AND INSERT AFTER THE HEAD BREAKAGE. SOME SCRATCHES AT THE FRONT FLAT SURFACE ARE VISIBLE AND ONE OF THE SETTING INSTRUMENT HOLES IS ENLARGED POSSIBLY DUE TO EXTRACTION FORCES APPLIED DURING THE REVISION SURGERY. THE BOTTOM SURFACE OF THE INSERT DOES NOT SHOW ANY DEFICIENCIES. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. RAW MATERIAL CERTIFICATE OF THE SULOX CERAMIC HEAD HAS BEEN REVIEWED AND CONFIRMED TO CONFORM TO THE SPECIFICATIONS. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: FRACTURE OF HEAD DUE TO INSUFFICIENT MATERIAL THICKNESS (WRONG DESIGN). NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. LOSS OF CONNECTION, FRACTURE OF CERAMIC HEAD DUE TO INAPPROPRIATE DESIGN CONCERNING PULL-OFF/TORQUE STRENGTH OF THE HEAD ON THE STEM TAPER. NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. LOSS OF CONNECTION, FRACTURE OF CERAMIC HEAD DUE TO PARTICLES BETWEEN STEM AND HEAD TAPER. POSSIBLE: THERE IS NO INFORMATION AVAILABLE CONFIRMING THAT, HOWEVER IT CANNOT BE EXCLUDED. FRACTURE OF HEAD TO DUE STEM TAPER CORROSION (INCREASING OF VOLUME) DUE TO WRONG MATERIAL PAIRING. NOT POSSIBLE: MATERIAL PAIRING WAS CORRECT. MAL-FUNCTION OF THA (WEAR, FRACTURE, DISLOCATION ETC.) DUE TO WRONG SIZE OF HEAD DIAMETER AND/OR OFFSET. POSSIBLE: CORRECT SIZE DIAMETER WAS USED, BUT OFFSET CORRECTNESS CANNOT BE DETERMINED DUE TO ABSENCE OF X-RAYS. HIGH WEAR, HEAD FRACTURE DUE TO WRONG RAW MATERIAL SELECTION NOT POSSIBLE: QUALITY DOCUMENTS FOR THE MATERIAL HAVE BEEN REVIEWED. THE CONFORMITY WITH SPECIFICATIONS HAS BEEN CONFIRMED. COMPROMIZED TAPER FIXATION STRENGTH, FRACTURE OF IMPLANT DUE TO HIGH PATIENT ACTIVITY, PATIENT DISREGARDS LIMITS OF THE DEVICE POSSIBLE: PATIENT'S ACTIVITY LEVEL IS MEDIUM, THEREFORE CANNOT BE EXCLUDED. LOSS OF CONNECTION, FRACTURE OF CERAMIC HEAD DUE TO USE ON A USED OR DAMAGED STEM TAPER POSSIBLE: IT IS NOT KNOWN IF THE STEM WAS DAMAGED DURING THE OPERATION, THEREFORE CANNOT BE EXCLUDED. INCREASED WEAR, FRETTING CORROSION ON STEM TAPER (LEVER TORQUE) DUE TO PATIENT WITH HIGH BODY WEIGHT POSSIBLE: PATIENT BMI=26, WHICH IS CLASSIFIED AS OVERWEIGHT. CONCLUSION SUMMARY: ACCORDING TO THE INFORMATION AVAILABLE AT THE HAND, PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2017 DUE TO HEAD BREAKAGE AFTER 1 YEAR 2 MONTHS IN-VIVO TIME. NEITHER X-RAYS, PRIMARY OPERATIVE NOTES NOR OFFICE VISIT NOTES WERE RECEIVED. THE BROKEN CERAMIC HEAD AND PE INSERT WERE RECEIVED FOR THE INVESTIGATION OF THE CASE. PARTS OF THE HEAD ARE MISSING. IN TOTAL 4.5 % OF VOLUME OF THE FEMORAL HEAD IS MISSING. THEREFORE, FRACTURE ORIGIN COULD NOT BE IDENTIFIED. THE REVIEW OF THE DHR INDICATES THAT THE HEAD MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE RESPECTIVE QUALITY DATA FOR THE CERAMIC HEAD (ANALYSIS OF RAW MATERIAL, SINTERING PROTOCOL, DENSITY MEASUREMENT, MEASUREMENT OF GRAIN SIZE AND INSPECTION CERTIFICATE) HAVE BEEN REVIEWED AND CONFIRMED TO CONFORM TO THE SPECIFICATIONS. THE PRODUCTION AND QUALITY DATA ARE THEREFORE WITHIN THE SPECIFICATIONS. POSSIBLE REASONS OF THE HEAD BREAKAGE CAN INCLUDE WRONG POSITION OF THE THA COMPONENTS, MISALIGNMENT OF THE HEAD ON STEM TAPER, 3RD BODY PARTICLES LEFT BETWEEN STEM AND HEAD TAPER DURING OP, WRONG SIZE OF HEAD OFFSET, HIGH PATIENT ACTIVITY, PATIENT DISREGARDING LIMITS OF THE DEVICE, USE OF THE HEAD ON A DAMAGED STEM TAPER AND PATIENT WITH HIGH BODY WEIGHT (BMI OF PATIENT IS 26 WHICH IS CLASSIFIED AS OVERWEIGHT). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A SULOX HEAD, M, 28/0, TAPER 12/14 ON (B)(6) 2016 ON AN UNKNOWN SIDE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO PAIN AND BROKEN IMPLANT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A SULOX HEAD, M, A, 28/0, TAPER 12/14 ON AN UNKNOWN SIDE ON (B)(6) 2017 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO PAIN AND BREAKAGE OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632162 SULOX HEAD, M, A, 28/0, TAPER 12/14 ALUMINA CERAMIC HEADS LZO ZIMMER GMBH N/A 2844251

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R