BEUDAMED
    FDA Adverse Event Other Summary report: N

    METASUL LDH, HEAD, 52, CODE R, TAPER 18/20

    MDR report key: 3772691 · Received March 3, 2014

    Report

    Report Number
    9613350-2014-03336
    Event Type
    Other
    Date Received
    March 3, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 20, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. A TIGHT MONITORING IS ONGOING FOR REVISIONS WITH OUTSIDE US DUROM CUPS WHERE THE INITIAL IMPLANT DATE OCCURRED AFTER THE ACCOMPLISHMENT OF A RETRAINING PROGRAM FOR USERS OUTSIDE THE USA WHICH WAS INITIATED IN 11/2009 AS A CORRECTIVE ACTION AND REPORTED TO THE NATIONAL COMPETENT AUTHORITIES AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE USA. A SIMILAR CUP, COMPATIBLE WITH THE METASUL LDH FEMORAL HEAD IS CLEARED IN THE USA AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN 07/2008 AS NOTIFICATION Z-2415/2426-2008. THE NEED FOR FURTHER CORRECTIVE MEASUREMENTS IS NOT INDICATED AT THIS TIME. ZIMMER REF NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE PROVIDED INFORMATION HAS BEEN MADE AVAILABLE. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE COMPATIBILITY CHECK SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER REVIEW OF INCOMING INFORMATION: PATIENT RECEIVED THE PRODUCTS ON (B)(6) 2010 AND UNDERWENT REVISION SURGERY ON (B)(6) 2014 DUE TO PAIN, WEAR AND METALLOSIS. ONLY HEAD AND HEAD ADAPTER HAS BEEN REVISED. NO X-RAYS WERE PROVIDED REVIEW OF OP REPORTS: IMPLANTATION REPORT DATED (B)(6) 2010: A (B)(6) MALE PATIENT UNDERWENT THA DUE TO AVASCULAR NECROSIS OF THE RIGHT HIP. PATIENT HAD A HISTORY OF LEFT THA DATED (B)(6) 2008 AND OF AN INTERPOSITIONAL GRAFT INTO RIGHT HIP. DURING SURGERY, ACETABULUM WAS FOUND TO BE "SLIGHTLY VERTICAL" AND THEREFORE HAS BEEN REPOSITIONED. IT WAS UNCLEAR IF IT WAS MEANT THAT THE ACETABULAR COMPONENT OF THE THA WAS MALPOSITIONED. REVISION REPORT DATED (B)(6) 2014: PATIENT UNDERWENT TO REVISION SURGERY DUE TO "FAILED THA SECONDARY TO CONTINUED METALLOSIS FROM MOM DUROM PROSTHESIS". PATIENT HAD SIMILAR ISSUE ON THE LEFT HIP THAT BECAME MORE COMPLICATED DUE TO SECONDARY INFECTION. DURING SURGERY, SIGNIFICANT FLUID HAS BEEN FOUND. TISSUE ANALYSIS DID NOT REVEALED SIGNS OF ACUTE INFLAMMATION AND NO INFECTION DETECTED. CUP FOUND TO BE WELL FIXED. SURGEON DECIDED TO REMOVE ONLY THE HEAD AND THE HEAD ADAPTER. DEVICE ANALYSIS: THE DEVICE ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO SAP DFMEA # 100281, REV 4: INCREASED RELEASE OF WEAR PARITCLES -> DUE TO 3RD BODY WEAR DUE TO PARTICLES. POSSIBLE, AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. CANNOT BE EXCLUDED; INCREASED RELEASE OF WEAR PARTICLES -> DUE TO SCRATCHES ON ARTICULATED SURFACE FROM SURGEONS. POSSIBLE, AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. CANNOT BE EXCLUDED; INCREASED WEAR DUE TO REDUCED SPHERICITY -> DUE TO REDUCED STIFFNESS DUE TO WEIGHT REDUCTION GROOVE AND DEPENDING ON HEAD DIAMETER AND OFFSET. POSSIBLE, AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. CANNOT BE EXCLUDED; INCREASED ARTICULATION AND TAPER INTERFACE WEAR -> DUE TO MICRO SEPERATION INFLUENCED BY CLEARANCE AND COMPONENT WEIGHT . POSSIBLE, AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. CANNOT BE EXCLUDED; INCREASED WEAR -> DUE TO REDUCED SPHERICITY DUE TO ASSEMBLING FORCE. POSSIBLE, AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. CANNOT BE EXCLUDED; FRETTING CORROSION DUE TO MICRO MOTION ON TAPER -> DUE TO BEHAVIOR (CONNECTION STRENGTH, CORROSION) OF 8/10 TAPER IS WORSE THAN 12/14 TAPER. POSSIBLE, AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. CANNOT BE EXCLUDED; ADVERSE BODY REACTIONS (LIKE CYST FORMATION, PSEUDOTUMORS, ALVAL, METALLOSIS AND PAIN) DUE TO ION RELEASE -> DUE TO INCREASED ION RELEASE DUE TO INCREASED METAL SURFACE (WITHOUT WEAR AND FRETTING CORROSION. POSSIBLE, AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. CANNOT BE EXCLUDED; ADVERSE BODY REACTIONS (LIKE CYST FORMATION, PSEUDOTUMORS, ALVAL, METALLOSIS AND PAIN) DUE TO ION RELEASE -> DUE TO INCREASED ION/WEAR RELEASE DUE TO INCREASED ARTICULAR DIAMETER. POSSIBLE -> PRODUCT NOT RETURNED FOR INVESTIGATION. CANNOT BE EXCLUDED; IINCREASED WEAR, LOSS OF TAPER CONNECTION, DISLOCATION -> DUE TO HIGH PATIENT ACTIVITY. NO DETAILS KNOWN ABOUT PATIENT ACTIVITY; INCREASED WEAR, FRETTING CORROSION (LEVER TORQUE) -> DUE TO PATIENT WITH HIGH BODY WEIGHT AND BMI. NO DETAILS KNOWN ABOUT PATIENT WIEGHT; INCREASED WEAR, LOSS OF TAPER CONNECTION, DISLOCATION -> DUE TO INCREASED ANTE/RETRO-VERSION OF THE STEM MAY INCREASE JOINT LOADING. POSSIBLE, AS NO DETAILS ABOUT STEM POSITIONING, NEITHER IN THE IMPLANTATION NOR IN THE REVISION REPORT. REPOSITIONING OF THE DUROM CUP DURING PRIMARY IMPLANTATION MAY HAVE CONTRIBUTED TO THE GENERATION OF WEAR AT THE LEVEL OF THE STEM/HEAD ADAPTER CONNECTION. THIS PROBLEM IS WELL KNOWN AND CORRECTIVE MEASURES WERE ALREADY IMPLEMENTED. NEITHER X-RAYS, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT(S) WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT(S) WERE UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY WERE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL WAS UNKNOWN. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED ON AUGUST 17, 2017. DHR REVIEW: THE QUALITY RECORDS INDICATE THAT THESE COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REVIEW OF INTERNAL DOCUMENTS : THE SURGICAL TECHNIQUE FOR METASUL® LDH® LARGE DIAMETER HEAD AND SURGICAL TECHNIQUE FOR ZIMMER MMC CUP; CONFIRM THE COMPATIBILITY OF THE COMPONENTS. ADDITIONALLY, IN MMC SURGICAL TECHNIQUE IT IS STATED THAT "A RANGE OF 40 TO A MAXIMUM OF 45 DEGREES INCLINATION (ABDUCTION) AND APPROPRIATE ANTEVERSION" SHOULD BE CHOSEN. ADDITIONALLY, IT IS STATED "NOTE: IF ADEQUATE IMPLANT STABILITY IS NOT ACHIEVED WITH A PRESS-FIT USING THE ZIMMER MMC CUP DESIGN, A SWITCH TO A MODULAR PRESS-FIT CUP OFFERING SUPPLEMENTARY FIXATION OPTIONS IS SUGGESTED AT THIS STAGE OF SURGERY." NEITHER X-RAYS, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT(S) WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT(S) IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. INVESTIGATION CONCLUSION SUMMARY: 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 AGAIN. (B)(4).

    Description of Event or Problem · 1

    THE PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF DUROM/LDH SYSTEM. IT WAS REPORTED THE PT WAS IMPLANTED AN UNK DUROM ACETABULAR CUP ON THE RIGHT SIDE ON (B)(6) 2010 AND A REVISION SURGERY HAS NOT BEEN PERFORMED. THE PT IS BEING MONITORED DUE TO PAIN. THIS IS A BILATERAL CLAIM. THE LEFT HIP COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED IN DECEMBER 14, 2015. IT HAS NOW BEEN REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014 DUE TO PAIN, WEAR AND METALLOSIS. ONLY HEAD AND HEAD ADAPTER HAS BEEN REVISED.

    Description of Event or Problem · 1

    IT WAS NOW REPORTED THAT THE PATIENT WAS IMPLANTED A METASUL LDH, HEAD, 52, CODE R, TAPER 18/20 ON THE RIGHT SIDE ON (B)(6) 2010 TOGETHER WITH AN MMC CUP. THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PAIN AND METALLOSIS. DURING REVISION, FLUID COLLECTION AND WEAR WAS NOTED. ONLY HEAD AND HEAD ADAPTER HAVE BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128433 METASUL LDH, HEAD, 52, CODE R, TAPER 18/20 METASUL LARGE DIAMETER HEAD KWA ZIMMER GMBH N/A 2423191

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other