BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PFM-R DISTAL STEM

    MDR report key: 7333448 · Received March 13, 2018

    Report

    Report Number
    0009613350-2018-00348
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    February 9, 2018
    Report Date
    September 6, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE MISSING INFORMATION WAS REQUESTED AT COMPLAINANT THE LATEST ONE ON (B)(6) 2018 BUT WAS NOT AVAILABLE. 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 IN 2006 WITH A PFM-R STEM AND UNDERWENT A REVISION SURGERY 12 YEARS POST IMPLANTATION DUE TO BREAKAGE. THE DEVICE WAS BROKEN BELOW THE JUNCTION OF THE TWO MODULAR PARTS. THE PATIENT HAS NO MEDIAL BONE SUPPORT AND MASSIVE BONE RESUMPTION. THE PATIENT IS ALSO THINKING ABOUT RAISING A CLAIM. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW OF REVITAN REVISION STEM SYSTEM , AS THIS IS THE SUCCESSOR DEVICE OF PFM-R STEM SIMILAR DESIGN, INTENDED USE: - ABRASIVE WEAR, DISLOCATION, METALLOSIS, ASEPTIC LOOSENING OF STEM, IMPLANT BREAKAGE DUE TO DIFFERENT THERMAL EXPANSION OF COMPONENTS => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. -IMPLANT BREAKAGE DUE TO INSUFFICIENT FATIGUE STRENGTH => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - IMPLANT BREAKAGE DUE TO NOTCHING DUE TO LASER MARKINGS ON STEMS IN HIGH STRESSED AREAS => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - IMPLANT BREAKAGE DUE TO MICROMOTION BETWEEN DISTAL STEM AND PIN LEADING TO PIN FRACTURE (E.G. FRETTING) => POSSIBLE, THE EXPLANTS HAVE NOT BEEN RETURNED FOR INVESTIGATION. THUS, THIS CANNOT BE EXCLUDED. - IMPLANT BREAKAGE DUE TO STEM WALL THICKNESS AROUND MODULAR CONNECTION (CONNECTION PIN) IS TOO SMALL => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - CORROSION DAMAGE LEADS TO IMPAIRMENT OF IMPLANT PARTS OR FRACTURE DUE TO INSUFFICIENT MATERIAL CORROSION RESISTANCE LEADING TO GENERAL CORROSION (CREVICE, FRETTING, PITTING, GALVANIC) OF IMPLANT DEVICE => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - IMPLANT BREAKAGE DUE TO DESIGN SPECIFICATION NOT MET => NOT POSSIBLE -> AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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. ADDITIONALLY, A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - IMPLANT BREAKAGE, BONE FRACTURE DUE TO WRONG PLANNING TEMPLATE USED / MISINTERPRETATION OF THE X-RAY TEMPLATES REGARDING CENTER OF ROTATION/LEG LENGTH/OFFSET => POSSIBLE, NO X-RAYS WERE RECEIVED FOR REVIEW AND ASSESSMENT. . THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - DAMAGE OF MATERIAL/ IMPLANT BREAKAGE DUE TO WRONG HANDLING OF DEVICE IN OR E.G DUE TO MISSING/ UNCLEAR INFORMATION => POSSIBLE, NO SURGICAL REPORT OF IMPLANTATION WAS RECEIVED FOR REVIEW AND ASSESSMENT. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - IMPLANT BREAKAGE/ DISLOCATION DUE TO WRONG POSITION OF DISTAL FEMORAL COMPONENT/ WRONG ANTETORSION FOR PROXIMAL PART CHOSEN => POSSIBLE, NO X-RAYS WERE RECEIVED FOR REVIEW AND ASSESSMENT. . THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - IMPLANT BREAKAGE DUE TO USAGE OF A WET AND/OR UNCLEAN CONNECTING TAPER => POSSIBLE, NO SURGICAL REPORT OF IMPLANTATION WAS RECEIVED FOR REVIEW AND ASSESSMENT. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - IMPLANT BREAKAGE DUE TO PROXIMAL AND DISTAL COMPONENT NOT FIRMLY TIGHTENED => POSSIBLE, NO SURGICAL REPORT OF IMPLANTATION WAS RECEIVED FOR REVIEW AND ASSESSMENT. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - IMPLANT BREAKAGE DUE TO EXCESSIVE IMPACTION LOAD/ TORQUE APPLIED TO STEMS WHILE ASSEMBLING LEADING TO DAMAGE OF MATERIAL => POSSIBLE, NO SURGICAL REPORT OF IMPLANTATION WAS RECEIVED FOR REVIEW AND ASSESSMENT. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - IMPLANT BREAKAGE DUE TO USAGE OF A WET AND/OR UNCLEAN CONNECTING TAPER => POSSIBLE, NO SURGICAL REPORT OF IMPLANTATION WAS RECEIVED FOR REVIEW AND ASSESSMENT. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - IMPLANT BREAKAGE DUE TO PROXIMAL AND DISTAL COMPONENT NOT FIRMLY TIGHTENED => POSSIBLE, NO SURGICAL REPORT OF IMPLANTATION WAS RECEIVED FOR REVIEW AND ASSESSMENT. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - IMPLANT BREAKAGE DUE TO EXCESSIVE IMPACTION LOAD/ TORQUE APPLIED TO STEMS DURING ASSEMBLING LEADING TO DAMAGE OF MATERIAL => POSSIBLE, NO SURGICAL REPORT OF IMPLANTATION WAS RECEIVED FOR REVIEW AND ASSESSMENT. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - IMPLANT BREAKAGE/ DISLOCATION DUE TO WRONG POSITION OF ASSEMBLED FEMORAL COMPONENT/ WRONG ANTETORSION FOR PROXIMAL PART CHOSEN => POSSIBLE, NO X-RAYS WERE RECEIVED FOR REVIEW AND ASSESSMENT. . THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - IMPLANT BREAKAGE DUE TO USAGE OF A WET AND/OR UNCLEAN TAPER/HEAD => POSSIBLE, NO SURGICAL REPORT OF IMPLANTATION WAS RECEIVED FOR REVIEW AND ASSESSMENT. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - IMPLANT BREAKAGE DUE TO OFF LABEL USE/ WRONG COMBINATION OF COMPONENTS USED/COMBINATION WITH COMPETITOR PRODUCTS => POSSIBLE, NO INFORMATION OF THE USED/COMBINED DEVICES WAS RECEIVED. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - IMPLANT BREAKAGE DUE TO INSUFFICIENT DESCRIPTION OF SURGICAL PROCESS LEADS TO INTRAOPERATIVE ERRORS OR MISUSE OF IMPLANT OUTSIDE OF ITS SCOPE (E.G. SELECTION OF HEAVY PATIENTS AND/ OR INSUFFICIENT PROXIMAL BONE SUPPORT) => POSSIBLE, NO INFORMATION ABOUT PATIENT WEIGHT WAS RECEIVED. IN ADDITION NO INFORMATION (E.G. X-RAYS) WERE RECEIVE TO EVALUATE SUFFICIENT BONE SUPPORT. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. - IMPLANT BREAKAGE DUE TO INAPPROPRIATE ADVICE BY SURGEON TO INFORM PATIENT ON ACTIVITIES AND LIMITS. => POSSIBLE, THE ADVICE ON ACTIVITIES AND LIMITS GIVEN TO THE PATIENT IS UNKNOWN. ADDITIONAL, ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. CONCLUSION SUMMARY: IT WAS REPORTED, THAT A PATIENT UNDERWENT AROUND 12 YEARS POST-OP A REVISION SURGERY DUE TO IMPLANT BREAKAGE. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS 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. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. 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 ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E ALLOCLASSIC OFFSET STEM 0, K033664) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. NO SURGICAL REPORT OR X-RAYS WERE PROVIDED FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A PFMR HIP STEM AND WAS REVISED DUE TO IMPLANT FRACTURE AFTER ABOUT 12 YEARS IN VIVO. THE STEM FRACTURED BELOW THE JUNCTION OF THE TWO MODULAR PARTS. NO MEDIAL BONE SUPPORT AND A MASSIVE BONE RESUMPTION HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177596 UNKNOWN PFM-R DISTAL STEM UNKNOWN JDI ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R UNKNOWN HEAD HIP, REF#UNK, LOT#UNK| UNKNOWN PFM-R PROXIMAL STEM, REF#UNK, LOT#UNK| UNKNOWN HEAD HIP, REF#UNK, LOT#UNK| UNKNOWN PFM-R PROXIMAL STEM, REF#UNK, LOT#UNK