BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9256032 · Received October 30, 2019

    Report

    Report Number
    1818910-2019-110092
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    July 10, 2006
    Report Date
    October 8, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. (B)(4).

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ENTITLED, ¿REVISION HIP ARTHROPLASTY WITH S-ROM PROSTHESIS: A STUDY OF CLINICAL OUTCOMES AND IMPLANT STABILITY¿ PUBLISHED BY JOURNAL OF ORTHOPAEDIC TRAUMATOLOGY (2006), VOL. 7, PP. 182-186, DOI 10.1007/S10195-006-0145-6, WAS REVIEWED. THIS ARTICLE REVIEWS THE CLINICAL OUTCOMES AND IMPLANT STABILITY FOLLOWING TOTAL HIP REVISIONS USING THE S-ROM IMPLANT. BETWEEN 1996 TO 2001, THE AUTHORS PERFORMED 62 CEMENTLESS REVISION HIP ARTHROPLASTIES USING THE S-ROM THA PROSTHESIS. DATA ON 54 PATIENTS WERE AVAILABLE FOR STUDY, WITH A MEAN FOLLOW-UP OF 4.5 YEARS. THE REVISED COMPONENTS WERE NOT PROVIDED IN THE ARTICLE AND ARE UNKNOWN. RESULTS: HARRIS HIP SCORES IMPROVED FROM A PREOPERATIVE VALUE OF 40 TO 80 POINTS AT THE LAST AVAILABLE FOLLOW-UP. 52 STEMS (96%) WERE RADIOLOGICALLY STABLE ON THE FINAL FOLLOW-UP. THERE WAS NO STEM RE-REVISION DUE TO LOOSENING. ON THE ACETABULAR SIDE, THE CUP WAS STABLE IN 51 HIPS (94.5%) AND THERE WAS MINIMAL SHIFT IN ONLY 3 CASES. 4 INSTANCES OF PERSISTENT PAIN AND LIMP. 32 CASES OF FEMORAL OSTEOLYSIS IDENTIFIED ON SERIAL RADIOLOGICAL STUDIES- NO REVISION REQUIRED. 2 CASES OF JOINT INSTABILITY, BOTH HAD FEMORAL SUBSIDENCE. ONE PATIENT DIED OF UNRELATED CAUSES BEFORE REVISION. THE OTHER PATIENT HAD REVISION OF THE FEMORAL HEAD TO INCREASE NECK LENGTH. IN THIS PATIENT, THE STEM WAS FOUND TO HAVE STABLE FIBROUS INGROWTH AND THE SURGEONS LEFT THE STEM AND SLEEVE IN SITU. THE JOINT INSTABILITY IS ATTRIBUTED TO THE SUBSIDENCE OF THE STEM AND FEMORAL HEAD NECK LENGTH. THIS PATIENT DID NOT EXPERIENCE ANY DISLOCATIONS. 3 CASES OF ACETABULAR CUP MIGRATION- NO REVISION OR INTERVENTION REQUIRED. 2 DISLOCATIONS TREATED WITH CLOSED REDUCTION. 16 HETEROTOPIC OSSIFICATION. 3 INTRAOPERATIVE CORTICAL PERFORATIONS DURING SEATING OF THE STEM- TREATMENT UNSPECIFIED. CODED BONE INJURY. 5 INTRAOPERATIVE CRACK FRACTURES- LOCATION UNKNOWN. 3 DEEP VENOUS THROMBI. 2 TROCHANTERIC NON-UNION- NO TREATMENT REQUIRED. PRODUCTS CAPTURED IN COMPLAINT: S-ROM CUP, HEAD, LINER, STEM, AND SLEEVE. THERE WAS ONE INSTANCE OF SURGICAL INTERVENTION THAT INCLUDED A REVISION OF THE FEMORAL HEAD TO CORRECT JOINT INSTABILITY. THERE WAS ONE PATIENT AWAITING REVISION FOR JOINT INSTABILITY WHO DID OF UNRELATED CAUSES BEFORE THE SCHEDULED SURGERY. THE 3 SLIGHT CUP MIGRATIONS DID NOT REQUIRE ANY INTERVENTION OR REVISION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050994 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention