BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM SOLUTION

    MDR report key: 13994314 · Received April 4, 2022

    Report

    Report Number
    1818910-2022-06020
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    July 30, 2021
    Report Date
    April 4, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED KIM YH, JANG YS, PARK JW, KIM EJ. COMBINED STRUT ONLAY ALLOGRAFTING, REDUCTION OSTEOTOMY, AND EXTENSIVELY POROUS-COATED STEM FOR RECONSTRUCTION OF SEVERE FEMORAL DEFECTS DURING REVISION HIP ARTHROPLASTY. J ARTHROPLASTY. 2021 NOV;36(11):3722-3727. DOI: 10.1016/J.ARTH.2021.07.011. EPUB 2021 JUL 30. PMID: 34392992. OBJECTIVE AND METHODS: THE PURPOSE OF THIS STUDY IS TO DETERMINE THE LONG-TERM (UP TO 27 YEARS) CLINICAL AND RADIOGRAPHIC RESULTS OF REVISION THAS USING A BARDEN¿S TECHNIQUE, PARTICULARLY REGARDING COMPONENT FIXATION AND THE FATE OF CORTICAL STRUT ONLAY ALLOGRAFTS. THE AUTHORS STUDIED 366 THA REVISIONS USING LONG EXTENSIVELY POROUS-COATED STEMS WITH CORTICAL STRUT ONLAY ALLOGRAFTS FOR PAPROSKY TYPE IIIB AND TYPE IV PROXIMAL FEMORAL DEFICIENCIES. OF THESE REVISIONS, 237 WERE THE FIRST REVISION, 86 WERE THE SECOND REVISION, AND 40 WERE THE THIRD REVISION. THE REVISED COMPONENTS WERE UNKNOWN. ALL PATIENTS RECEIVED THE DEPUY SOLUTIONS STEM, COMPETITOR CORTICAL STRUT AND ALLOGRAFT, AND AN UNK DEPUY FEMORAL HEAD. THE ACETABULAR COMPONENTS UTILIZED IN THE STUDY WERE UNKNOWN. THE MEAN RADIOGRAPHIC AND CLINICAL FOLLOW-UP WAS 23 YEARS. THE AUTHORS CONCLUDED THAT THERE WERE GOOD RESULTS IN TERMS OF LONGEVITY AND FUNCTIONAL OUTCOME USING THIS MODIFIED TECHNIQUE. FUTURE MECHANICAL STUDIES IN ADDITION TO CONTROLLED CLINICAL STUDIES ARE WARRANTED. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SOLUTIONS FEMORAL STEM, UNKNOWN FEMORAL HEAD. THIS COMPLAINT WILL CAPTURE ALL EVENTS POTENTIALLY ASSOCIATED WITH THE DEPUY DEVICES. RESULTS ASSOCIATED WITH THE COMPETITOR IMPLANTS WILL BE EXCLUDED. THE FEMORAL HEADS UTILIZED WITH THE STEMS ARE UNKNOWN. IT IS REASONABLE TO ASSUME THAT A DEPUY FEMORAL HEAD WAS PAIRED WITH THE DEPUY SOLUTIONS STEM, THOUGH THIS IS NOT CONFIRMED. THE ACETABULAR COMPONENTS UTILIZED IN THIS STUDY ARE UNKNOWN. THE RADIOGRAPHIC IMAGES IDENTIFIED PATIENT SPECIFIC RESULTS WHICH WILL BE CAPTURED BELOW. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY DEVICES: PATIENT SPECIFIC RESULTS: FIGURE 2: (B)(6) MALE. UNK THA REVISED TO TREAT FRACTURE OF THE UNKNOWN STEM PATIENT RECEIVED SOLUTIONS STEM/HEAD AND UNKNOWN ACETABULAR COMPONENTS. THE SOLUTIONS STEM/HEAD WERE EVENTUALLY REVISED WITH A COMPETITOR CONSTRUCT TO TREAT PERSISTENT PAIN. FIG 3: (B)(6) FEMALE. RECEIVED REVISION OF A CEMENTED CHARNLEY ELITE STEM, HEAD, CEMENTED CHARNLEY ALL-POLY CUP AND DOME SCREW TO TREAT PAIN. PATIENT RECEIVED A SOLUTIONS/STEM AND HEAD WITH UNKNOWN ACETABULAR COMPONENTS. NON-PATIENT SPECIFIC RESULTS: 10 REPORTS OF ASEPTIC LOOSENING OF THE STEM. NO TREATMENT IS SPECIFIED. 17 REPORTS SEPTIC LOOSENING OF THE STEM. ALL RECEIVED IRRIGATION AND DEBRIDEMENT WITH 6-WEEK IV ANTIBIOTICS. IN ALL 17 STEMS AND HEADS, THE I&D WAS UNSUCCESSFUL. 16 WERE THEN REVISED WITH A LARGER SOLUTIONS STEM AND HEAD AND 1 WAS REVISED TO A COMPETITOR PRODUCT. 4 REPORTS OF DISPLACED FEMORAL BONE FRACTURE TREATED WITH ALLOGRAFT AND CORTICAL STRUTS. 4 REPORTS OF DISLOCATION SECONDARY TO MIGRATION OF THE STEM TREATED WITH REVISION OF THE FEMORAL PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78323 UNK HIP FEMORAL STEM SOLUTION FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNKNOWN HIP ACETABULAR CUP| UNKNOWN HIP ACETABULAR LINERS