BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9203592 · Received October 17, 2019

    Report

    Report Number
    1818910-2019-110457
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    July 7, 2017
    Report Date
    September 20, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (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

    LITERATURE ARTICLE ENTITLED, ¿SUBTROCHANTERIC SHORTENING OSTEOTOMY DURING CEMENTLESS TOTAL HIP ARTHROPLASTY IN YOUNG PATIENTS WITH SEVERE DEVELOPMENTAL DYSPLASIA OF THE HIP¿ BY DUAN WANG, ET AL, PUBLISHED BY BMC MUSCULOSKELETAL DISORDERS (2017), VOL. 18, 13 PAGES, DOI 10.1186/S12891-017-1857-X, WAS REVIEWED FOR MDR REPORTABILITY. THIS RETROSPECTIVE STUDY WAS DESIGNED TO DETERMINE COMPLICATIONS, FUNCTIONAL AND RADIOGRAPHIC RESULTS OF TRANSVERSE SUBTROCHANTERIC OSTEOTOMY DURING CEMENTLESS, MODULAR TOTAL HIP ARTHROPLASTY (THA) IN A SERIES OF ACTIVE PATIENTS YOUNGER THAN 45 YEARS WITH CROWE TYPE-III OR IV DEVELOPMENTAL DYSPLASIA OF THE HIP (DDH). SEVERE PAIN UNRESPONSIVE TO NON-OPERATIVE MANAGEMENT, PELVIC OBLIQUITY, AND FUNCTIONAL IMPAIRMENT WITH LIMP IN DAILY ACTIVITIES WERE THE INDICATION FOR SURGERY. THERE WERE 9 MALES AND 40 FEMALES WITH MEAN AGE OF 36.9 YEARS AT THE TIME OF INDEX THA. PREVIOUS SCHANZ OSTEOTOMY WAS PERFORMED IN TWO PATIENTS. MODULAR FEMORAL STEM (S-ROM, DEPUY) WITH POROUS-COATED ACETABULAR COMPONENT (PINNACLE, POROCOAT, DEPUY) WAS IDENTICAL IN ALL HIPS. THERE WERE 8 MOP AND 48 COC ARTICULATIONS USED. THERE WERE 26 28-MM, 22 32-MM, AND 8 36-MM FEMORAL HEADS INSERTED. BONE UNION OF OSTEOTOMY SITE WAS ARCHIVED IN FIFTY-FOUR HIPS WITH NO COMPLICATION. SERIAL RADIOGRAPHS SHOWED TWO CASES (4.1%) OF NONUNION AT OSTEOTOMY SITE. ASYMPTOMATIC BROOKER CLASS-I AND II HETEROTOPIC OSSIFICATION WERE OBSERVED IN THREE AND TWO HIPS, RESPECTIVELY. FOCAL OSTEOLYSIS WAS OBSERVED IN FIVE HIPS ON FOLLOW-UP RADIOGRAPHS, BUT THE CUPS SHOWED BONY INCORPORATION AND NO SURGERY WAS REQUIRED. 4 PATIENTS COMPLAINED OF POST-OPERATIVE LIMB ASYMMETRY. THERE WERE NO REPORTED INFECTIONS, DVTS. OR VASCULAR INJURIES. THERE WERE 3 CASES OF POST-OPERATIVE DISLOCATION, 3 CASES OF TRANSIENT NERVE PALSY THAT WERE FULLY RESOLVED, AND TWO CASES OF INTRAOPERATIVE FRACTURE. THE AUTHORS NOTE THAT THE OSTEOTOMY CARRIED AND RISK OF NERVE INJURY AND FURTHER NOTED THAT THEIR SURGICAL TECHNIQUE AT THE BEGINNING OF THE STUDY MAY HAVE CONTRIBUTED TO THE PALSY. THE NERVE PALSY RESOLVED WITHIN ONE YEAR WITHOUT FUNCTIONAL DEFECT FOR ALL PATIENTS. THE AUTHORS PROVIDED DETAIL REGARDING THE PATIENTS REQUIRING INTERVENTION LABELED WITHIN THIS GUIDANCE DOCUMENT LABELED CASE 1-13. THE AUTHORS DO NO PROVIDE INFORMATION REGARDING THE MATERIAL MAKE-UP OR SIZE OF EACH PATIENT¿S IMPLANTS. THE PARENT PC CAPTURES THE PATIENT EVENTS NOT IDENTIFIED BY PATIENT NUMBER. IN TOTAL, THERE WERE 7 PATIENTS WHO REQUIRED REOPERATIONS OR REVISION SURGERY. ALL COMPONENTS USED WITHIN THIS STUDY WERE DEPUY PRODUCTS. PATIENT HAD AN ACETABULAR AND GREATER TROCHANTER POST-OPERATIVE FRACTURE, AS WELL AS A FRACTURED ACETABULAR SCREW 7 YEARS AFTER INDEX THA. THE FRACTURED SCREW AND BONES CAUSED THE ACETABULAR CUP TO BE LOOSENED. TX: CUP AND LINER REVISION WITH ACETABULAR BONE GRAFTING SURGERY. NO FURTHER COMPLICATIONS WERE SEEN. SURGEON NOTES THAT THE LOOSENING OF THE CUP WAS DUE TO THE FRACTURE OF THE BONES AND SCREW. THE SURGEON DOES NOT ATTRIBUTE THE CUP LOOSENING TO THE ACETABULAR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997070 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention