BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IC-BIPOLAR HEAD

    MDR report key: 10060351 · Received May 15, 2020

    Report

    Report Number
    3012523063-2020-00005
    Event Type
    Injury
    Date Received
    May 15, 2020
    Date of Event
    April 14, 2020
    Report Date
    June 18, 2020
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    KWY
    PMA / PMN Number
    K191569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF MDR REPORTABLE EVENT RECEIVED BY IMPLANTCAST IMPLANTCAST RECEIVED THE FOLLOWING REPORT FROM A LICENCE PARTNER ON 16-APR-2020: 'FIRST BIPOLAR HIP SURGERY WAS PERFORMED ON (B)(6) 2020. HOWEVER, REVISION SURGERY WAS REQUIRED 1 MONTH LATER, BECAUSE BIOLOX FORTE HEAD WAS DISLOCATED FROM THE IC-BIPOLAR HEAD. AT THIS TIME, THE SAFETY RING WASN'T RELEASED. THEREFORE, REVISION SURGERY WAS PERFORMED ON (B)(6) 2020.' IMPLANTCAST RECEIVED FOLLOW-UP INFORMATION FROM THE KOREAN LICENCE PARTNER ON 19-MAY-2020: 'THE DISLOCATION OF BIPOLAR HEAD (REMARK IMPLANTCAST: FROM THE NATURAL ACETABULUM) IS THE REASON FOR THE REVISION SURGERY. [...] THE REVISION SURGERY WAS DECIDED DUE TO DISLOCATION OF BIPOLAR HEAD. THE FORTE HEAD WAS DISLOCATED FROM BIPOLAR HEAD DURING REDUCTION IN REVISION SURGERY. AT THAT TIME SAFETY RING REMAINED IN PLACE.' ON 27-MAY-2020 THE AFFECTED DEVICES WERE AVAILABLE AT IMPLANTCAST GMBH FOR INSPECTION. DAMAGE ANALYSIS: OPTICAL INSPECTION. THE FOLLOWING DEVICES ARE AVAILABLE FOR INSPECTION: IC-BIPOLAR HEAD COCRMO Ø 28/52MM (REF 21510052 / LOT 185129486). IC-HEAD BIOLOX® FORTE TAPER 12/14MM Ø 28MM, M (REF 25872805 / LOT 1283133). ON THE INNER EDGE OF THE SAFETY RING SEVERAL NOTCHES CAN BE OBSERVED. BLACKISH DISCOLORATIONS OF UNKNOWN ORIGIN CAN BE SEEN IN THE BIOLOX HEAD. FURTHER ABNORMALITIES CANNOT BE OBSERVED. ASSESSMENT OF THE MANUFACTURING PROTOCOLS: THE MANUFACTURING PROTOCOLS OF THE MEDICAL DEVICES IC-BIPOLAR HEAD COCRMO Ø 28/52MM (REF: 21510052 / LOT: 185129486, RELEASE DATE 04-OCT-2019) AND OF THE IC-HEAD BIOLOX® FORTE TAPER 12/14MM Ø 28MM, M (REF: 25872805 / LOT: 1283133, RELEASE DATE 06-MAR-2019) WERE CHECKED. THESE SHOW NO DEVIATIONS. ASSESSMENT OF THE DIMENSIONAL ACCURACY OF THE CONSTRUCTION: THERE IS NO INDICATION FOR A DEVIATION OF THE DIMENSIONAL ACCURACY. WITH REGARD TO THE REF NUMBERS THE AFFECTED DEVICES ARE COMPATIBLE. FUNCTIONAL TESTING: A FUNCTIONAL TESTING COULD NOT BE CARRIED OUT FOR THE ERROR PATTERN LUXATION / DISLOCATION. ASSESSMENT OF THE MECHANICAL PROPERTIES: THE APPROVAL OF THE BASIC MATERIALS WAS PERFORMED. EXTERNAL EVALUATION: AN EXTERNAL EVALUATION WAS NOT PERFORMED. THE INTERNAL INVESTIGATIONS PROVIDE A SUFFICIENT CONCLUSION ABOUT A POSSIBLE CAUSE. ASSESSMENT OF THE MEDICAL RECORDS: PATIENT GENDER: UNKNOWN. AGE AT TIME OF EVENT: UNKNOWN. WEIGHT: UNKNOWN. HEIGHT: UNKNOWN. INDICATION: UNKNOWN. PAST MEDICAL HISTORY: DATE OF IMPLANTATION: (B)(6) 2020. EXPLANTATION DATE: (B)(6) 2020. DEGREE OF ACTIVITY: UNKNOWN. AN X-RAY IS AVAILABLE FOR INSPECTION. THE X-RAY SHOWS THE DISLOCATED (LUXATED) IC-BIPOLAR HEAD FROM THE ACETABULUM. HOWEVER, A DISCONNECTION (SEPARATION) BETWEEN THE IC-BIPOLAR HEAD AND THE BIOLOX TAPER CANNOT BE OBSERVED ON THIS PICTURE. THE DATE THE X-RAY WAS TAKEN IS UNKNOWN. SURGICAL TECHNIQUE AND INSTRUCTIONS FOR USE: THE SURGICAL TECHNIQUE 'IC BIPOLAR HEAD' DESCRIBES THE COMPLETE IMPLANTATION PROCESS IN DETAIL. THERE ARE NO INDICATIONS OF AN INCORRECT OR INCOMPLETE SURGICAL TECHNIQUE. THE INSTRUCTION FOR USE (IFU) 'IC-HEADS' WAS CHECKED. THERE IS NO INDICATION OF INCORRECT INSTRUCTIONS FOR USE. RISK ANALYSIS AND TREND EVALUATION: WITHIN THE RISK ANALYSIS OF THE 'UNIPOLAR AND BIPOLAR HEAD' SYSTEM AN ACCEPTED RATE OF OCCURRENCE OF (B)(4) WAS DETERMINED FOR THE RISK OF LUXATION / DISLOCATION. DURING THE PAST 3 YEARS, NO FURTHER CASE OF A LUXATION / DISLOCATION OF AN IC-BIPOLAR FROM THE NATURAL ACETABULUM HAS BEEN BROUGHT TO IMPLANTCAST'S ATTENTION. SUMMARY OF FOLLOW-UP INSPECTION REPORT: THE MANUFACTURING PROTOCOLS OF THE AFFECTED PRODUCTS WERE CHECKED. THESE SHOW NO DEVIATIONS. AN X-RAY AND THE AFFECTED DEVICES WERE AVAILABLE FOR INSPECTION. THE X-RAY SHOWS A DISLOCATED (LUXATED) IC-BIPOLAR HEAD FROM THE NATURAL ACETABULUM. THE FOLLOW-UP INFORMATION RECEIVED ON 19-MAY-2020 REVEALED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE DISLOCATION. SUBSEQUENTLY, DURING THE PHYSICIAN'S ATTEMPT OF REPOSITIONING THE IC-BIPOLAR HEAD INTO THE NATURAL ACETABULUM A DISCONNECTION BETWEEN IC-BIPOLAR HEAD AND THE BIOLOX® FORTE TAPER TOOK PLACE. THE DISCONNECTION CAN THEREFORE BE SEEN AS A RESULT OF THE PHYSICIAN'S ATTEMPT TO REPOSITION. THE OPTICAL INSPECTION OF THE DEVICE SHOWS SEVERAL NOTCHES ON THE SAFETY RING OF THE BIPOLAR HEAD. IT CAN BE ASSUMED THAT THESE NOTCHES WERE CREATED WHEN TRYING TO REPOSITION THE BIPOLAR HEAD. WHAT ORIGINALLY LED TO THE DISLOCATION OF THE BIPOLAR HEAD FROM THE NATURAL ACETABULUM IS UNKNOWN. THE CALCULATED RATE OF OCCURRENCE FOR THE RISK OF DISLOCATION / LUXATION LIES BELOW THE ACCEPTED VALUE OF (B)(4) WITHIN RISK MANAGEMENT. NO MEASURES REQUIRED.

    Description of Event or Problem · 0

    IMPLANTCAST RECEIVED THE FOLLOWING REPORT FROM A LICENSE PARTNER ON 16-APR-2020: 'FIRST BIPOLAR HIP SURGERY WAS PERFORMED IN (B)(6) 2020. HOWEVER, REVISION SURGERY WAS REQUIRED 1 MONTH LATER, BECAUSE BIOLOX FORTE HEAD WAS DISLOCATED FROM THE IC-BIPOLAR HEAD. AT THIS TIME, THE SAFETY RING WASN'T RELEASED. THEREFORE, REVISION SURGERY WAS PERFORMED IN (B)(6) 2020.' IMPLANTCAST RECEIVED FOLLOW-UP INFORMATION FROM THE KOREAN LICENCE PARTNER ON 19-MAY-2020: 'THE DISLOCATION OF BIPOLAR HEAD (REMARK IMPLANTCAST: FROM THE NATURAL ACETABULUM) IS THE REASON FOR THE REVISION SURGERY. [...].THE REVISION SURGERY WAS DECIDED DUE TO DISLOCATION OF BIPOLAR HEAD. THE FORTE HEAD WAS DISLOCATED FROM BIPOLAR HEAD DURING REDUCTION IN REVISION SURGERY. AT THAT TIME SAFETY RING REMAINED IN PLACE.' ON 27-MAY-2020 THE AFFECTED DEVICES WERE AVAILABLE AT IMPLANTCAST GMBH FOR INSPECTION.

    Additional Manufacturer Narrative · 1

    DESCRIPTION OF MDR REPORTABLE EVENT RECEIVED BY IMPLANTCAST. IMPLANTCAST RECEIVED THE FOLLOWING REPORT FROM A LICENSE PARTNER ON (B)(6) 2020: 'FIRST BIPOLAR HIP SURGERY WAS PERFORMED IN (B)(6) 2020. HOWEVER, REVISION SURGERY WAS REQUIRED 1 MONTH LATER, BECAUSE BIOLOX FORTE HEAD WAS DISLOCATED FROM THE IC-BIPOLAR HEAD. AT THIS TIME, THE SAFETY RING WASN'T RELEASED. THEREFORE, REVISION SURGERY WAS PERFORMED IN (B)(6) 2020.' DAMAGE ANALYSIS. OPTICAL INSPECTION. AN OPTICAL INSPECTION OF THE AFFECTED MEDICAL DEVICE COULD NOT BE PERFORMED. SO FAR, THE DEVICE IS NOT AVAILABLE FOR INSPECTION. ASSESSMENT OF THE MANUFACTURING PROTOCOLS. THE MANUFACTURING PROTOCOLS OF THE MEDICAL DEVICES IC-BIPOLAR HEAD COCRMO Ø 28/52MM (REF: 21510052 / LOT: 185129486, RELEASE DATE (B)(6) 2019) AND OF THE IC-HEAD BIOLOX® FORTE TAPER 12/14MM Ø 28MM, M (REF: 25872805 / LOT: 1283133, RELEASE DATE (B)(6) 2019) WERE CHECKED. THESE SHOW NO DEVIATIONS. ASSESSMENT OF THE DIMENSIONAL ACCURACY OF THE CONSTRUCTION AS NO PRODUCT IS AVAILABLE FOR INSPECTION, AN ASSESSMENT OF THE DIMENSIONAL ACCURACY COULD NOT BE PERFORMED. FUNCTIONAL TESTING: AS NO PRODUCT IS AVAILABLE FOR INSPECTION, A FUNCTIONAL TESTING COULD NOT BE PERFORMED. ASSESSMENT OF THE MECHANICAL PROPERTIES: THE APPROVAL OF THE BASIC MATERIALS WAS PERFORMED. EXTERNAL EVALUATION: AS NO EXPLANT IS AVAILABLE FOR INSPECTION, AN EXTERNAL EVALUATION WAS NOT COMMISSIONED. ASSESSMENT OF THE MEDICAL RECORDS: PATIENT GENDER: UNKNOWN. AGE AT TIME OF EVENT: UNKNOWN. WEIGHT: UNKNOWN. HEIGHT: UNKNOWN. INDICATION: UNKNOWN. PAST MEDICAL HISTORY: DATE OF IMPLANTATION: (B)(6) 2020. EXPLANTATION DATE: (B)(6) 2020. DEGREE OF ACTIVITY: UNKNOWN. AN X-RAY IS AVAILABLE FOR INSPECTION. THE X-RAY SHOWS THE DISLOCATED (LUXATED) IC-BIPOLAR HEAD FROM THE ACETABULUM. HOWEVER, A DISCONNECTION (SEPARATION) BETWEEN THE IC-BIPOLAR HEAD AND THE BIOLOX TAPER CANNOT BE OBSERVED ON THIS PICTURE. THE DATE THE X-RAY WAS TAKEN IS UNKNOWN. SURGICAL TECHNIQUE AND INSTRUCTIONS FOR USE . THE SURGICAL TECHNIQUE ']IC BIPOLAR HEAD' DESCRIBES THE COMPLETE IMPLANTATION PROCESS IN DETAIL. THERE ARE NO INDICATIONS OF AN INCORRECT OR INCOMPLETE SURGICAL TECHNIQUE. THE INSTRUCTION FOR USE (IFU) 'IC-HEADS' WAS CHECKED. THERE IS NO INDICATION OF INCORRECT INSTRUCTIONS FOR USE. SUMMARY: NO MEDICAL DEVICE / NO IMAGES OF THE MEDICAL DEVICE ARE AVAILABLE FOR INSPECTION. THE MANUFACTURING PROTOCOLS OF THE AFFECTED PRODUCTS WERE CHECKED. THESE SHOW NO DEVIATIONS. AN X-RAY TAKEN ON AN UNKNOWN DATE WAS AVAILABLE FOR INSPECTION. THE X-RAY SHOWS A DISLOCATED (LUXATED) IC-BIPOLAR HEAD FROM THE NATURAL ACETABULUM. HOWEVER, A DISCONNECTION (SEPARATION) BETWEEN THE IC-BIPOLAR HEAD AND THE BIOLOX® FORTE TAPER (AS STATED IN THE INITIAL REPORT) CANNOT BE OBSERVED ON THE X-RAY. FURTHER INFORMATION WAS REQUESTED FROM THE REPORTER TO CLARIFY THE CONFLICTING DATA. SO FAR, IMPLANTCAST CONSIDERS THIS CASE AS NOT ASSESSABLE.

    Description of Event or Problem · 1

    IMPLANTCAST RECEIVED THE FOLLOWING REPORT FROM A LICENSE PARTNER ON (B)(6) 2020: 'FIRST BIPOLAR HIP SURGERY WAS PERFORMED IN (B)(6) 2020. HOWEVER, REVISION SURGERY WAS REQUIRED 1 MONTH LATER, BECAUSE BIOLOX FORTE HEAD WAS DISLOCATED FROM THE IC-BIPOLAR HEAD. AT THIS TIME, THE SAFETY RING WASN'T RELEASED. THEREFORE, REVISION SURGERY WAS PERFORMED IN (B)(6) 2020.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527270 IC-BIPOLAR HEAD IC-BIPOLAR HEAD COCRMO Ø 28/52MM KWY IMPLANTCAST GMBH 21510052

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R IC-BIPOLAR HEAD COCRMO Ø 28/52MM| IC-BIPOLAR HEAD COCRMO Ø 28/52MM| IC-HEAD BIOLOX® FORTE TAPER 12/14MM Ø 28MM, M| IC-HEAD BIOLOX® FORTE TAPER 12/14MM Ø 28MM, M