BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL, ALPHA INSERT, HH/32

    MDR report key: 7376562 · Received March 28, 2018

    Report

    Report Number
    0009613350-2018-00389
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    February 24, 2018
    Report Date
    June 26, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: REVISION SURGERY DUE TO DISLOCATION OF THE INSERT. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION: THE DURASUL ALPHA INSERT WAS REVISED AFTER 5 DAYS IN VIVO DUE TO A DISLOCATION OF THE INSERT. REVIEW OF RECEIVED DATA: REVIEW OF AVAILABLE INFORMATION NEXT TO THE PRODUCT EXPERIENCE REPORT (PER) ONLY THE SURGICAL NOTES OF THE REVISION SURGERY WAS RECEIVED. THE ORIGINAL DOCUMENTS WERE RECEIVED IN GERMAN AND ARE TRANSLATED AND SUMMARIZED BELOW. ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (ZPER) ON THE ZPER THE ALLEGED EVENT IS DESCRIBED AS: ¿ON THE THIRD POSTOPERATIVE DAY THE PATIENT FELT A CRACK IN THE FRESHLY OPERATED JOINT DURING A MOVEMENT WHILE SEATED ON THE EDGE OF THE BED. AFTER X-RAY EXAMINATION DISLOCATION OF THE INLAY¿. AS METHOD FOR DISINFECTION ¿AUTOCLAVE¿ WAS CHECKED. SURGICAL NOTES, DATED 27 FEBRUARY 2018. THE PATIENT FELT A CRACK IN THE HIP JOINT DURING A MOVEMENT WHILE SITTING ON THE EDGE OF THE BED 3 DAYS POSTOPERATIVELY. THE PATIENT HAD RATHER LITTLE PAIN, BUT FURTHER CRACKING / SNAPPING DURING HIP MOVEMENTS. CLINICAL EXAMINATION AND X-RAYS HIGHLY INDICATE A DISLOCATION OF THE INSERT. THE PROSTHESIS IS EXPOSED AFTER A LATERAL CENTERED INCISION OVER THE GREATER TROCHANTER. THE HEAD IS IN A SUBLUXATED POSITION TO CRANIOLATERAL WITH A CAUDALLY TILTED AND LOOSE INSERT. THE JOINT IS LUXATED AND THE INSERT LIES LOOSELY IN THE SHELL. AFTER REMOVAL OF THE HEAD AND THE INSERT, THE LATTER SHOWS NO OBVIOUS DAMAGE NOR IS THE INSIDE OF THE SHELL DAMAGED. THE POLE LOCKING SCREW SITS TIGHT, FLUSH AND IS NOT TILTED. THE SHELL IS ABSOLUTELY FIXED IN THE ORIGINAL AND CORRECT POSITION. THERE ARE ALSO NO DISTURBING OSTEOPHYTES OR TISSUES. AFTER EXTENSIVE LAVAGE, A NEW IDENTICAL INSERT IS IMPACTED. AFTER CHECKING, THE HEAD IS IMPACTED AND THE JOINT REPOSITIONED. DEVICES ANALYSIS. VISUAL EXAMINATION: THE DURASUL ALPHA INSERT IS NOT ANYMORE IN ITS ORIGINAL CONDITION DUE TO THE AUTOCLAVING PROCESS PRIOR TO THE RECEIPT OF THE COMPONENT AT ZIMMER BIOMET WINTERTHUR AS CHECKED IN THE PER. MACHINE MARKS CAN BE OBSERVED ON THE ENTIRE INSERT AND SOME SLIGHT SUPERFICIAL SCRATCHES. THE RIM ON THE ARTICULATION SIDE EXHIBITS A SINGLE CUT WHICH MOST LIKELY OCCURRED DURING THE REVISION SURGERY. THE ARTICULATION SIDE OF THE INSERT IS INCONSPICUOUS. THE BACKSIDE OF THE INSERT WAS GOLD SPUTTERED FOR BETTER VISUALIZATION OF THE DIFFERENT PHENOMENA. IN THE SPHERICAL AREA ONE ISOLATED LONG SCRATCH, SLIGHT PUNCTURE INDENTATIONS AND SOME SLIGHT SCRATCHES ARE VISIBLE. THE POLE PIN SHOWS A VERTICAL CUT AND SOME SMALL AREAS WHERE NO MACHINING MARKS BUT SLIGHT DEFORMATIONS CAN BE OBSERVED. THE INDENTATIONS FROM THE FIXATION SPIKES ON THE SHELL ARE BARELY VISIBLE AND ARE DECENTERED LOCATED. IN TWO LOCATIONS ON THE RIM¿S LATERAL SURFACE SOME SLIGHT DAMAGE CAN BE OBSERVED. ONE OF THE DAMAGE SHOWS A PATTERN OF SCRATCHES. CONCLUSION: THE DURASUL ALPHA INSERT WAS REVISED AFTER 5 DAYS IN VIVO DUE TO A DISLOCATION OF THE INSERT. THE INSERT IS NOT ANYMORE IN ITS ORIGINAL CONDITION DUE TO THE AUTOCLAVING PROCESS PRIOR TO THE RECEIPT OF THE COMPONENT AT ZIMMER BIOMET WINTERTHUR. ON THE BACKSIDE OF THE INSERT THE INDENTATIONS FROM THE FIXATION SPIKES ON THE SHELL ARE BARELY VISIBLE AND ARE DECENTERED LOCATED. CORRECT INDENTATIONS (SIZE AND CENTERED LOCATION) WOULD INDICATE A PROPER FIXATION OF THE INSERT IN THE SHELL. IT IS SUPPOSED THAT THE CURRENT SIZE OF THE INDENTATIONS IS NOT THE ORIGINAL ONE DUE TO THE AUTOCLAVING PROCESS. HOWEVER, BECAUSE OF THE DECENTERED LOCATION OF THE INDENTATIONS IT COULD BE ASSUMED THAT THE INSERT WAS NOT PROPERLY SNAPPED INTO THE SHELL. AS A CONCOMITANT, THE INSERT WAS SLIGHTLY MOVING AND ROTATING WITHIN THE SHELL WHICH LED TO THE DAMAGE, SCRATCHES AND SLIGHT PUNCTURE INDENTATIONS SEEN ON THE BACKSIDE OF THE INSERT DUE TO THE UNINTENDED CONTACT WITH THE SHELL. BASED ON THE AVAILABLE INFORMATION NO FURTHER CONCLUSIONS CAN BE DRAWN. 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). THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00388.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY FIVE DAYS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: SULOX, HEAD, S, 32/-3.5, TAPER 12/14, CATALOG NO# 173205, LOT NO# 2915271; ALLOFT-S ALLOCLASSIC SHL 50/HH, CATALOG NO# 00000004264, LOT NO# 2422000; AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 5, TAPER 12/14, CATALOG NO# 0106010005, LOT NO# 2916445. THERAPY DATE : (B)(6) 2018. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220324 DURASUL, ALPHA INSERT, HH/32 DURASUL ALPHA INSERT LZO ZIMMER GMBH N/A 2916292

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R