BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/54

    MDR report key: 8965840 · Received September 5, 2019

    Report

    Report Number
    0002249697-2019-03118
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    April 27, 2018
    Report Date
    November 7, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    UDI-DI
    04546540639004
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING WEAR OF FEMORAL HEAD INVOLVING A ADM LINER WAS REPORTED. THE MEDICAL REVIEW REVEALED AND CONFIRMED OSTEOLYSIS. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICAL CONSULTANT INDICATED: "A SECOND X-RAY SET IS AVAILABLE WITH UNKNOWN DATE BUT SOME TIME IN 2018 BETWEEN FIRST AND SECOND REVISION TO DOCUMENT AN UNCHANGED AND STABLE POSITION OF THE RESTORATION MODULAR STEM IN THE FEMUR ALTHOUGH CLEAR EVIDENCE FOR OSTEOLYSIS IS EVIDENT NEAR THE PROXIMAL MEDIAL FEMORAL BONE, HOWEVER NOT AFFECTING THE BONY STABILITY OF THE STEM. ON THE ACETABULAR SIDE, SIGNIFICANT OSTEOLYSIS IS EVIDENT AROUND THE TRITANIUM SHELL INCLUDING PROGRESSIVE DAMAGE OF THE CENTRAL ACETABULAR AREA TO SUGGEST PELVIC SEPARATION BETWEEN SUPERIOR AND INFERIOR ACETABULAR BONE." "RETAINED CERAMIC DEBRIS IN AND AROUND THE HIP JOINT SPACE AFTER A CERAMIC BEARING FRACTURE WITH REVISION IN (B)(6) 2016, HAS CONTRIBUTED TO EXCESSIVE AND PREMATURE THIRD-BODY WEAR IN THE NEW MDM X3 POLY WITH COCHR FEMORAL HEAD REQUIRING A SECOND HIP REVISION SURGERY IN (B)(6) 2018 WITH EXCHANGE OF THE MDM BEARING AND FEMORAL HEAD. " PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE MANUFACTURING RECORDS INDICATE THAT ALL DEVICES ACCEPTED INTO FINAL STOCK WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE MEDICAL REVIEW REVEALED AND CONFIRMED THE OSTEOLYSIS. THE MEDICAL REVIEW ALSO REVEALED THAT RETAINED CERAMIC DEBRIS IN AND AROUND THE HIP JOINT SPACE AFTER A CERAMIC BEARING FRACTURE WITH REVISION IN (B)(6) 2016, HAS CONTRIBUTED TO EXCESSIVE AND PREMATURE THIRD-BODY WEAR IN THE NEW MDM X3 POLY WITH COCHR FEMORAL HEAD REQUIRING A SECOND HIP REVISION SURGERY IN (B)(6) 2018 WITH EXCHANGE OF THE MDM BEARING AND FEMORAL HEAD. NO FURTHER INVESTIGATION FOR THIS EVENT IS REQUIRED AT THIS TIME. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO WEAR OF THE METAL FEMORAL HEAD. SURGEON REPORTED THAT HE SUSPECTED THAT CERAMIC SHARDS REMAINED IN THE PATIENT FROM A 2016 REVISION ((B)(4)) WHICH CONTRIBUTED TO THE WEAR. BLACK TISSUE WAS NOTED INTRA-OPERATIVELY. THE PATIENT'S MDM/ ADM LINER CONSTRUCT AND 28 +4 LFIT FEMORAL HEAD WERE REVISED TO A 44G LINER AND 44MM BIOLOX HEAD WITH +4 SLEEVE. REP PROVIDED INTRA-OPERATIVE PICTURES, EXPLANT PICTURES, AND THE REVISION USAGE SHEET. THE REP MAY BE ABLE TO OBTAIN ADDITIONAL INFORMATION, BUT THE EXPLANTS ARE NOT AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO WEAR OF THE METAL FEMORAL HEAD. SURGEON REPORTED THAT HE SUSPECTED THAT CERAMIC SHARDS REMAINED IN THE PATIENT FROM A 2016 REVISION (PI 1232546) WHICH CONTRIBUTED TO THE WEAR. BLACK TISSUE WAS NOTED INTRA-OPERATIVELY. THE PATIENT'S MDM/ ADM LINER CONSTRUCT AND 28 +4 LFIT FEMORAL HEAD WERE REVISED TO A 44G LINER AND 44MM BIOLOX HEAD WITH +4 SLEEVE. REP PROVIDED INTRA-OPERATIVE PICTURES, EXPLANT PICTURES, AND THE REVISION USAGE SHEET. THE REP MAY BE ABLE TO OBTAIN ADDITIONAL INFORMATION, BUT THE EXPLANTS ARE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760260 RESTORATION ADM X3 INS 28/54 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO STRYKER ORTHOPAEDICS-MAHWAH 48882601 04546540639004

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R