BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 12688348 · Received October 25, 2021

    Report

    Report Number
    1818910-2021-23377
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    June 15, 2020
    Report Date
    October 11, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 NUMBER 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. DEVICE HISTORY LOT : A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LI J, JI Q, NI M, ZHENG Q, SUN J, ZHANG G. MANAGEMENT OF INTRAOPERATIVE ACETABULAR FRACTURE IN PRIMARY TOTAL HIP ARTHROPLASTY. BMC MUSCULOSKELET DISORD. 2020 JUN 15;21(1):383. DOI: 10.1186/S12891-020-03356-5. PMID: 32539748; PMCID: PMC7296652. OBJECTIVE AND METHODS: INTRAOPERATIVE ACETABULAR FRACTURE (IAF) IS A RARE COMPLICATION OF PRIMARY TOTAL HIP ARTHROPLASTY (THA). THE PREVIOUS REPORTS HAVE LACKED A SUFFICIENTLY LARGE NUMBER OF SUBJECTS TO ALLOW FOR AN ANALYSIS OF THE CAUSES AND APPROPRIATE TREATMENT OF THIS PROBLEM. THE PURPOSE OF THE PRESENT STUDY WAS TO RETROSPECTIVELY REVIEW A LARGER CONSECUTIVE SERIES OF PATIENTS WHO HAD SUSTAINED IAF OF THE ACETABULUM DURING PRIMARY THA. THE AUTHORS RETROSPECTIVELY REVIEWED 24 PATIENTS WHO WERE ALL TREATED WITH A POSTEROLATERAL APPROACH USING UNCEMENTED COMPONENTS THAT SUSTAINED INTRAOPERATIVE ACETABULAR FRACTURES BETWEEN 2015 AND 2018 (16 FEMALES AND 8 MALES). THE AUTHORS UTILIZED 13 PINNACLE CUPS AND LINERS AND 11 COMPETITOR ACETABULAR COMPONENTS. THE FEMORAL COMPONENTS CONSISTED OF 8 SROM STEMS WITH SLEEVES, 4 CORAIL STEMS, AND 13 COMPETITOR STEM/HEAD COMBINATIONS. TWENTY PATIENTS (83.3%) UNDERWENT SUPPLEMENTAL SCREW FIXATION, OF WHICH 2 PATIENTS WERE TREATED WITH STEEL PLATE FIXATION. TWO PATIENTS' FEMORAL HEADS WERE USED AS A GRAFT. IN 4 PATIENTS (16.7%), THE ACETABULAR COMPONENTS WERE JUDGED TO BE STABLE DESPITE THE FRACTURE AND NO ADDITIONAL TREATMENT WAS PERFORMED. ALL PATIENTS WERE EVALUATED CLINICALLY WITH HARRIS HIP SCORES (HHS) AND RADIOGRAPHICALLY WITH SERIAL X-RAYS WHICH FOLLOW UP FOR A MEAN PERIOD OF 34.0 ± 12.6 MONTHS. THE AUTHORS CONCLUDED THAT INTRAOPERATIVE ACETABULAR FRACTURES ARE RARE COMPLICATIONS OF THA, AND MOST COMMONLY OCCUR DURING THE IMPLANTATION OF THE ACETABULAR COMPONENTS. IT IS NECESSARY TO PREVENT THE OCCURRENCE OF FRACTURES AS MUCH AS POSSIBLE EVEN IF THE FRACTURES ARE FOUND DURING THE OPERATION. IT SHOULD BE NOTED THAT PATIENTS WITH ANKYLOSING SPONDYLITIS INVOLVING HIP JOINTS DURING THA SURGERY MUST BE CAREFUL TO PREVENT IAFS DURING DISLOCATION AND PRE-OSTEOTOMY. OF NOTE: THE AUTHORS PROVIDE A TABLE OF CUPS ASSOCIATED WITH PATIENT SPECIFICS. THE OTHER COMPLICATIONS NOTED IN THE ARTICLE, AS WELL AS THE ONE FRACTURE SUSTAINED DURING REAMING, ARE NOT PROVIDED WITH DEVICE MANUFACTURER OR PATIENT SPECIFICS. THESE EVENTS WILL BE CAPTURED WITH A QUANTITY OF ONE, AS THE ACTUAL NUMBER OF DEPUY DEVICES ASSOCIATED WITH THESE EVENTS IS UNKNOWN. THIS COMPLAINT WILL EXCLUDE EVENTS ASSOCIATED WITH KNOWN COMPETITOR PRODUCTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PINNACLE CUP, CORAIL STEMS, SROM STEMS AND SLEEVES, AND UNKNOWN DEPUY LINERS AND FEMORAL HEADS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH DEPUY DEVICES: PATIENT SPECIFIC RESULTS: CASE 2: PATIENT RECEIVED A PRIMARY THA TO TREAT AVN. PATIENT SUSTAINED AN INTRAOPERATIVE POSTERIOR ACETABULAR WALL FRACTURE DURING CUP IMPLANTATION WHICH WAS STABILIZED WITH 4 SCREWS. CASE 4: PATIENT RECEIVED A PRIMARY THA TO TREAT AVN. PATIENT SUSTAINED AN INTRAOPERATIVE POSTERIOR ACETABULAR WALL FRACTURE DURING CUP IMPLANTATION WHICH WAS STABILIZED WITH 3 SCREWS. CASE 5: PATIENT RECEIVED A PRIMARY THA TO TREAT AVN. PATIENT SUSTAINED AN INTRAOPERATIVE POSTERIOR AND MEDIAL ACETABULAR WALL FRACTURE DURING CUP IMPLANTATION WHICH WAS STABILIZED WITH 9 SCREWS AND A PLATE. IMAGES LOCATED IN FIG 2 (PP3) CASE 7: PATIENT RECEIVED A PRIMARY THA TO TREAT ANKYLOSING SPONDYLOSIS. PATIENT SUSTAINED AN INTRAOPERATIVE POSTERIOR ACETABULAR WALL FRACTURE DURING CUP IMPLANTATION WHICH WAS STABILIZED WITH 3 SCREWS AND A PLATE. CASE 8: PATIENT RECEIVED A PRIMARY THA TO TREAT ANKYLOSING SPONDYLOSIS. PATIENT SUSTAINED AN INTRAOPERATIVE ACETABULAR ANTERIOR COLUMN FRACTURE DURING CUP IMPLANTATION WHICH WAS STABILIZED WITH 1 SCREW. CASE 10: PATIENT RECEIVED A PRIMARY THA TO TREAT DDH. PATIENT SUSTAINED AN INTRAOPERATIVE POSTERIOR ACETABULAR WALL FRACTURE DURING CUP IMPLANTATION WHICH WAS STABILIZED WITH 1 SCREW. CASE 13: PATIENT RECEIVED A PRIMARY THA TO TREAT AVN. PATIENT SUSTAINED AN INTRAOPERATIVE MEDIAL ACETABULAR WALL FRACTURE DURING CUP IMPLANTATION WHICH WAS STABILIZED WITH 1 SCREW. CASE 14: PATIENT RECEIVED A PRIMARY THA TO TREAT OA. PATIENT SUSTAINED AN INTRAOPERATIVE POSTERIOR ACETABULAR WALL FRACTURE DURING CUP IMPLANTATION WHICH WAS STABILIZED WITH 14 SCREWS. CASE 19: PATIENT RECEIVED A PRIMARY THA TO TREAT AVN. PATIENT SUSTAINED AN INTRAOPERATIVE POSTERIOR ACETABULAR WALL FRACTURE DURING CUP IMPLANTATION WHICH WAS STABILIZED WITH 2 SCREWS. CASE 20: PATIENT RECEIVED A PRIMARY THA TO TREAT DDH. PATIENT SUSTAINED AN INTRAOPERATIVE POSTERIOR AND SUPERIOR ACETABULAR WALL FRACTURE DURING CUP IMPLANTATION WHICH WAS STABILIZED WITH 2 SCREWS. IMAGES LOCATED IN FIG 4 (PP4) CASE 21: PATIENT RECEIVED A PRIMARY THA TO TREAT DDH. PATIENT SUSTAINED AN INTRAOPERATIVE POSTERIOR ACETABULAR WALL FRACTURE DURING CUP IMPLANTATION WHICH WAS STABILIZED WITH 3 SCREWS. CASE 22: PATIENT RECEIVED A PRIMARY THA TO TREAT DDH. PATIENT SUSTAINED AN INTRAOPERATIVE POSTERIOR AND MEDIAL ACETABULAR WALL FRACTURE DURING CUP IMPLANTATION WHICH WAS STABILIZED WITH 2 SCREWS. CASE 24: PATIENT RECEIVED A PRIMARY THA TO TREAT ANKYLOSING SPONDYLOSIS. PATIENT SUSTAINED AN INTRAOPERATIVE ANTERIOR ACETABULAR WALL FRACTURE DURING CUP IMPLANTATION WHICH WAS STABILIZED WITH 2 SCREWS. NON-PATIENT SPECIFIC RESULTS: 1 ACETABULAR FRACTURE SUSTAINED DURING REAMING, TREATED WITH INTERNAL FIXATION. 1 INTRAOPERATIVE TROCHANTER FRACTURE TREATED WITH CERCLAGE WIRING. 1 DELAYED WOUND HEALING THAT RESOLVED AFTER ONE-YEAR OF UNSPECIFIED INVASIVE TREATMENT. 1 POSTOPERATIVE DISLOCATION TREATED WITH OPEN REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591789 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention