BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII MODULAR LONG NECK

    MDR report key: 10007083 · Received April 28, 2020

    Report

    Report Number
    0002249697-2020-00826
    Event Type
    Injury
    Date Received
    April 28, 2020
    Date of Event
    January 23, 2019
    Report Date
    June 26, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092406
    Removal / Correction Number
    Z-2089-2012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING REVISION DUE TO PSEUDOTUMORAL MASS INVOLVING A ABGII MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THE COMPLAINT DATABASES SHOW THERE HAVE BEEN OTHER EVENTS FOR THE REPORTED LOT. SIMILAR EVENTS HAVE OCCURRED FOR THE CATALOG NUMBER AND PRODUCT FAMILY. THESE EVENTS WERE DETERMINED TO BE ASSOCIATED WITH RA 2012-067. CONCLUSIONS. VOLUNTARY RECALL RA 2012-067 WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED REVISION DUE TO PSEUDOTUMORAL MASS IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    REVISION SURGERY FOLLOWING THIS SECOND EPISODE OF DISLOCATION, AN ASSESSMENT WAS CARRIED OUT. A CT SCAN OF THE LEFT HIP WAS PERFORMED ON (B)(6) 2018, WHICH REVEALED A MAJOR PERI-PROSTHETIC PSEUDOTUMORAL MASS INVADING THE PELVIS AND THE MUSCLES SURROUNDING THE PSOAS, PARTICULARLY THE PSOAS, WITH DISSEMINATED BONE EROSION. MR. SOT ALSO REPORTED THAT HE HAD HAD A FEELING OF MASS ABOVE THE LEFT ILIAC CREST FOR AT LEAST 8 MONTHS WHICH WAS NOT CORRECTLY RELIEVED BY PARACETAMOL. FINALLY, WE NOTE SEVERAL COBALTEMIA DOSAGES: 5.22 G ON (B)(6) 2013, 4.10 G ON (B)(6) 2014, 5.45 G ON (B)(6) 2014, 4.48 G ON (B)(6) 2016, 3.23 G ON (B)(6) 2017. FINALLY, MR. SOT WAS HOSPITALIZED FROM (B)(6) TO (B)(6) 2019 FOR RECOVERY. COMPLETE LEFT TOTAL HIP REPLACEMENT. THIS SURGERY WAS RELATED TO AN INAPPROPRIATE TISSUE REACTION AT THE INTERFACE OF THE ABG II PROSTHESIS. THE OPERATIVE COUNT INDICATES AN UNCOMPLICATED SURGERY ON (B)(6) 2019. AT DISCHARGE, THE PATIENT WAS ON ELIQUIS FOR ONE MONTH. THE PATIENT WAS GIVEN THE USUAL POSTURAL ADVICE TO AVOID FLEXION AND INTERNAL ROTATION ON THE FIRST SIX WEEKS. THE POSTOPERATIVE PICTURES OF (B)(6) 2019 SHOW A WELL ORIENTED PROSTHESIS, WITH COLLAR, CEMENT-FREE. MR SOT DOES NOT HAVE THE PATHOLOGY REPORT. NOR DOES HE HAVE COBALT DOSAGE IN INTRA-ARTICULAR FLUID. A LAST COBALT ASSAY WAS DONE ON (B)(6) 2019 AT 1.22 G. FOLLOW-UP WAS THEN REGULAR BUT NO RECORD OF CONSULTATIONS IS AVAILABLE. VARIOUS SHOTS ARE PRESENTED ON (B)(6) 2019 AND (B)(6) 2019. THESE ARE STABLE. THE ORTHOPAEDIST HAS RETAINED A CONSOLIDATION ON (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    REVISION SURGERY. FOLLOWING THIS SECOND EPISODE OF DISLOCATION, AN ASSESSMENT WAS CARRIED OUT. A CT SCAN OF THE LEFT HIP WAS PERFORMED ON (B)(6) 2018, WHICH REVEALED A MAJOR PERI-PROSTHETIC PSEUDOTUMORAL MASS INVADING THE PELVIS AND THE MUSCLES SURROUNDING THE PSOAS, PARTICULARLY THE PSOAS, WITH DISSEMINATED BONE EROSION. (B)(6) ALSO REPORTED THAT HE HAD HAD A FEELING OF MASS ABOVE THE LEFT ILIAC CREST FOR AT LEAST 8 MONTHS WHICH WAS NOT CORRECTLY RELIEVED BY PARACETAMOL. FINALLY, WE NOTE SEVERAL COBALTEMIA DOSAGES: 5.22 ¿G ON (B)(6) 2013. 4.10 ¿G ON (B)(6) 2014. 5.45 ¿G ON (B)(6) 2014. 4.48 ¿G ON (B)(6) 2016. 3.23 ¿G ON (B)(6) 2017. FINALLY, (B)(6) WAS HOSPITALIZED FROM (B)(6) 2019 FOR RECOVERY. COMPLETE LEFT TOTAL HIP REPLACEMENT. THIS SURGERY WAS RELATED TO AN INAPPROPRIATE TISSUE REACTION AT THE INTERFACE OF THE ABG II PROSTHESIS. THE OPERATIVE COUNT INDICATES AN UNCOMPLICATED SURGERY ON (B)(6) 2019. AT DISCHARGE, THE PATIENT WAS ON ELIQUIS FOR ONE MONTH. THE PATIENT WAS GIVEN THE USUAL POSTURAL ADVICE TO AVOID FLEXION AND INTERNAL ROTATION ON THE FIRST SIX WEEKS. THE POSTOPERATIVE PICTURES OF (B)(6) 2019 SHOW A WELL ORIENTED PROSTHESIS, WITH COLLAR, CEMENT-FREE. (B)(6) DOES NOT HAVE THE PATHOLOGY REPORT. NOR DOES HE HAVE COBALT DOSAGE IN INTRA-ARTICULAR FLUID. A LAST COBALT ASSAY WAS DONE ON (B)(6) 2019 AT 1.22 ¿G. FOLLOW-UP WAS THEN REGULAR BUT NO RECORD OF CONSULTATIONS IS AVAILABLE. VARIOUS SHOTS ARE PRESENTED ON (B)(6) 2019 AND (B)(6) 2019. THESE ARE STABLE. THE ORTHOPAEDIST HAS RETAINED A CONSOLIDATION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471552 ABGII MODULAR LONG NECK PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC MEH STRYKER ORTHOPAEDICS-MAHWAH G2688071

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R