BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOLOX HEAD

    MDR report key: 7137250 · Received December 21, 2017

    Report

    Report Number
    0009613350-2017-01811
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    March 3, 2014
    Report Date
    August 8, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: IF FOLLOW-UP, WHAT TYPE. CORRECTION: DATE OF REPORT, PMA/510K. AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED SEVERAL TIMES TO RECEIVE ADDITIONAL INFORMATION FOR THIS CASE. DEVICE HISTORY RECORDS (DHR): AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE MISSING DEVICE INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. AT ZIMMER GMBH ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER GMBH AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. TREND ANALYSIS: NO TREND ANALYSIS COULD BE PERFORMED AS NO ITEM NUMBER(S) IS/ARE AVAILABLE. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A CERAMIC HEAD AND UNDERWENT A REVISION SURGERY 13 DAYS POST IMPLANTATION DUE TO INFECTION. THIS IS A SPLIT CASE, FOR DEVICES MANUFACTURED BY ZIMMER INC., WARSAW SEE (B)(4) (MFR 0001822565-2017-08530). THE PATIENT HAD LONG HISTORY OF PAIN AND UNDERWENT RIGHT TOTAL THA; PATIENT EXPERIENCED 3 DISLOCATIONS AND WAS SUBSEQUENTLY REVISED, THE DEVICE TREATED IN THE CASE AT HAND WAS IMPLANTED IN THIS REVISION SURGERY. MEDICAL HISTORY WITH HIS RIGHT HIP: 3,5 MONTHS POST IMPLANTATION DISLOCATION WITH CLOSED REDUCTION (THIS CASE IS FILED UNDER (B)(4) AND FOR DEVICES MANUFACTURED BY ZIMMER INC., WARSAW SEE (B)(4). SECOND DISLOCATION 1 YEAR POST IMPLANTATION (THIS CASE IS FILED UNDER (B)(4) AND FOR DEVICES MANUFACTURED BY ZIMMER INC., WARSAW SEE (B)(4). REVISION SURGERY AFTER THIRD DISLOCATION (THIS CASE IS FILED UNDER (B)(4) AND FOR DEVICES MANUFACTURED BY ZIMMER INC., WARSAW SEE (B)(4). REVIEW OF RECEIVED DATA: REPORT OF IMPLANTATION OF THE PRIMARY THA, DATED ON (B)(6) 2013. DIAGNOSIS: DEGENERATIVE JOINT DISEASE, RIGHT HIP. SURGERY INDICATION (SUMMARY) 62-YEAR-OLD MALE PATIENT WITH A LONG HISTORY OF PROGRESSIVELY INCREASING PAIN IN HIS RIGHT HIP. IT WAS DECIDED THAT THE BENEFIT OF DOING SIMPLE ARTHROSCOPY AND DEBRIDEMENT WOULD NOT BE ENOUGH, AS AN MRI SHOWED THAT THIS PATIENT HAS SIGNIFICANT DEGENERATIVE JOINT DISEASE. THERE IS NOTHING REMARKABLE WRITTEN IN THE REPORT ABOUT THE PERFORMED SURGICAL PROCEDURE . NO COMPLICATIONS. POST OP-REPORTS OF ON (B)(6) 2013 AND ON (B)(6) 2013. THE REPORTS STATES THAT THE PATIENT IS DOING WELL AND THE DEVICES ARE IN EXCELLENT POSITIONS. RECOMMENDATIONS AND DISCUSSIONS: " I DEMONSTRATED FOR HIM HOW HE CAN SAFELY BEND OVER AND REACH HIS FEET, OR PICK SOMETHING UP OFF THE FLOOR." DOCTOR REPORT, DATED ON (B)(6) 2013. THE REPORT DESCRIBES THE POSTERIOR DISLOCATION HAPPENED ON (B)(6) 2013. DOCTOR REPORT, DATED ON (B)(6) 2014. THE REPORT DESCRIBES THE SECOND DISLOCATION. RADIOGRAPHIC FINDINGS FROM ON (B)(6) 2014. THE FINDINGS INDICATE RIGHT HIP IN EXCELLENT POSITION AND ALIGNMENT WITH NO EVIDENCE OF LOOSENING, POLY WEAR AND OSTEOLYSIS. REPORT OF EXPLANTATION AND IMPLANTATION OF THE DEVICE TREATED IN THE CASE AT HAND, DATED ON (B)(6) 2014. PREOPERATIVE DIAGNOSIS: RECURRENT DISLOCATIONS, STATUS POST RIGHT TOTAL HIP; CHRONIC ILIOPSOAS TENDINITIS, STATUS POST RIGHT TOTAL HIP. THE OPERATIVE REPORT STATES THERE WAS NO EVIDENCE OF ANY INFECTION. IT WAS NOTED THAT THE FEMORAL HEAD WAS QUITED SCRATCHED, CONSISTED WITH THE PRIOR DISLOCATIONS. ALSO HAD A LITTLE BIT OF METALLOSIS AND SOME STAINED SOFT TISSUE. ON CAREFUL INSPECTION, IT APPEARED THAT THE SHOULDER FEMORAL COMPONENT WAS IN EXTERNAL ROTATION CONTACTING THE SUPEROLATERAL RIM OF THE ACETABULAR COMPONENT WHICH IS THE CAUSE OF METALLOSIS. IT WAS ALSO NOTED THAT THE ILIOPSOAS TENDON WAS TIGHT AND ANTERIOR POSTERIOR-INFERIOR ASPECT OF THE ACETABULAR DID OVERHANG THE BONY ACETABULAR RIM. THE FEMORAL NECK, HEAD AND ACETABULAR POLYETHYLENE LINER WERE EXPLANTED. LOCKING RING WAS PLACED OVER THE HEAD AND NECK AND THEN REDUCED FEMORAL HEAD INTO CONSTRAINED LINER. RANGE OF MOTION WAS FOUND QUITE STABLE. REPORT OF EXPLANTATION AND IMPLANTATION, DATED ON (B)(6) 2014. PREOPERATIVE DIAGNOSIS: DRAINING HEMATOMA, STATUS POST REVISION RIGHT TOTAL HIP. PROCEDURE: DEEP IRRIGATION AND DEBRIDEMENT WITH EVACUATION OF HEMATOMA AND EXCHANGE OF THE ACETABULAR POLYETHYLENE LINER AND THE FEMORAL HEAD, RIGHT TOTAL HIP. INDICATIONS: THE OPERATIVE REPORT STATES THAT WHEN PATIENT WAS DISCARDED 3 DAYS POST IMPLANTATION HE WAS DOING FINE. A FEW DAYS LATER, HE BEGAN TO HAVE BLOODY DRAINAGE FROM THE INFERIOR ASPECT OF HIS WOUND. IT WAS CLEAR THAT HE HAD A DRAINING HEMATOME. AS PATIENT IS HIV-POSITIVE IT WAS ELECTED TO TREAT HIM AGGRESSIVELY AS THE DOCTOR FELT THIS WAS A DRAINING HEMATOMA WITH POTENTIONAL FOR DEVELOPING INFECTION. EXTENSIVE IRRIGATION AND DEBRIDEMENT WITH EXCHANGE OF THE FEMORAL HEAD AND THE ACETABULAR LINER WILL BE PERFORMED. DESCRIPTION OF PROCEDURE: THE OPERATIVE REPORT STATES THAT THE OLD INCISION WAS REOPENED, AND SIMPLY BY CUTTING THE SUTURES. IT WAS REALLY NOT NEEDED TO DO ANY FURTHER INCISION OF TISSUE. A LARGE CLEAN-APPEARING HEAMATOMA WAS ENCOUNTERED. AN EXTENSIVE IRRIGATION AND DEBRIDEMENT AND EVACUATION OT THIS HEMATOMA WAS DONE. ALL QUESTIONABLE OR NECROTIC-APPEARING MATERIAL WAS EXCISED. THE FEMORAL HEAD AND THE LINER WERE REMOVED. A NEW CONTAINED PE LINER AND CERAMIC HEAD WERE IMPLANTED. 2 SINGLE MEDIUM DRAINS DEEP IN THE WOUND WERE PLACED. DOCTOR REPORT, DATED ON (B)(6) 2014. HISTORY OF PRESENT ILLNESS: PATIENT IS A MONTH OUT FROM REVISION DONE FOR RECURRENT DISLOCATIONS. ABOUT A WEEK LATER, HE PRESENTED WITH DRAINING HEMATOMA. THE HEMATOMA WAS WASHED OUT DURING A SURGERY. INTRAOPERATIVE CULTURES GREW COAG-NEGATIVE STAPH, SENSITIVE BASICALLY TO EVERYTHING. PATIENT IS ON DAPTOMYCIN AND IS DOING FINE AND FEELING BETTER ALL THE TIME. PHYSICAL EXAMINATION: THE WOUND IS CLEAN, DRY AND HEALING NICELY. THERE IS NO DRAINAGE. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE AVAILABLE INFORMATION, THE PRODUCT LOCATION IS UNKNOWN. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW : NON-STERILE DEVICE IS IMPLANTED DUE TO STERILIZATION PROCESS FAILURE. NOT POSSIBLE : THE STERILIZATION METHOD IS VALIDATED ACCORDING TO THE STERILIZATION SPECIFICATION. NON-STERILE DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE POSSIBLE, THE PACKAGING OF THE PRODUCT IS VALIDATED ACCORDING TO THE PACKAGING SPECIFICATION. NEVERTHELESS, ONE SHOULD CHECK THE PRODUCT BEFORE OPENING THE PACKAGING REGARDING THE EXISTENCE OF ANY IMPERFECTION/DEFORMATION. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED AS THE HANDLING OF THE DEVICE OUTSIDE OF ZIMMER BIOMET, IS OUT OF ZIMMER BIOMET 'CONTROL. NON-STERILE DEVICE IS IMPLANTED DUE TO SURGEON RESTERILIZES HEAD POSSIBLE, IFU D011500245 CHAPTER "WARNINGS - SINGLE USE ONLY - DO NOT RE-USE" AND SYMBOL ON BOX LABEL: "NOT TO BE RE-USED" IS PROVIDED TO CUSTOMERS. HOWEVER, STILL IT IS NOT SURELY KNOWN WHETHER THE DEVICE WAS USED BEFORE OR NOT. NON-STERILE DEVICE IS IMPLANTED DUE TO PACKAGING IS DAMAGED DUE TO INADEQUATE HANDLING DURING TRANSPORTATION, STORAGE POSSIBLE, THE HANDLING OF THE DEVICE OUTSIDE OF ZIMMER BIOMET, IS OUT OF ZIMMER BIOMET'S CONTROL. NON-STERILE DEVICE IS IMPLANTED, CROSS CONTAMINATION DUE TO EXPLANTED CERAMIC HEAD IS REUSED WITH THE SAME OR NEW FEMORAL STEM POSSIBLE, IFU D011500245 CHAPTER "WARNINGS - SINGLE USE ONLY - DO NOT RE-USE" AND SYMBOL ON BOX LABEL: "NOT TO BE RE-USED" IS PROVIDED TO CUSTOMERS. HOWEVER, STILL IT IS NOT SURELY KNOWN WHETHER THE DEVICE WAS USED BEFORE OR NOT. NON-STERILE DEVICE IS IMPLANTED, CROSS CONTAMINATION DUE TO INAPPROPRIATE INFORMATION ON PACKAGING LABEL OR NOT LEGIBLE PACKAGING LABEL LEADS TO INCORRECT USE OF IMPLANT (E.G. USE OF EXPIRED PRODUCT, RESTERILIZATION OF HEAD) POSSIBLE, SINCE THE DEVICE AND PRODUCT NUMBER WAS NOT RECEIVED IT CANNOT BE VERIFIED IF THE DEVICE WAS CORRECT USED. CONCLUSION SUMMARY: A PATIENT EXPERIENCED AROUND 13 DAYS POST IMPLANTATION A DRAINING HEMATOMA AND UNDERWENT A SURGERY FOR DEEP IRRIGATION AND DEBRIDEMENT WITH EVACUATION OF HEMATOMA. THE HEAD AND LINER WERE EXCHANGED. MEDICAL DOCUMENTS DESCRIBE INTRAOPERATIVE CULTURES GREW COAG-NEGATIVE STAPH. SPECIFIC STERILIZATION SPECIFICATION OF THE DEVICE COULD NOT BE REVIEWED AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT DESIGN FAVORED OR CONTRIBUTED TO THE INFECTION. HOWEVER, THE IFU FOR ENDOPROSTHESIS D011500200 STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. NEVERTHELESS, POSSIBLE CAUSES OF INFECTION INCLUDE WRONG HANDLING OF DEVICE DUE TO WRONG INFORMATION, WRONG RESTERILIZATION PROCEDURES FOR STERILE DELIVERED PARTS OR PACKAGING FAILURE DURING TRANSPORTATION. 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 GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX HEAD ON THE LEFT SIDE ON (B)(6) 2014 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014 DUE TO HEMATOMA AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916393 UNKNOWN BIOLOX HEAD LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R