BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTOR3D

    MDR report key: 16142803 · Received January 11, 2023

    Report

    Report Number
    3014833750-2023-00001
    Event Type
    Injury
    Date Received
    January 11, 2023
    Date of Event
    December 13, 2022
    Report Date
    January 5, 2023
    Manufacturer
    RESTOR3D
    Product Code
    PHX
    PMA / PMN Number
    520(B) EXMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS A PATIENT-SPECIFIC CUSTOM PRODUCT. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUE RELATED TO MANUFACTURING AND/OR DESIGN THAT WOULD HAVE CONTRIBUTED TO THE EVENT. PRODUCT WAS NOT RECEIVED FOR EVALUATION AS IT REMAINED IMPLANTED IN THE PATIENT; HOWEVER, RESTOR3D SENT A REPRESENTATIVE TO ATTEND THE REVISION SURGERY CASE ON (B)(6) 2022, WHERE THEY WERE ABLE TO INTERVIEW THE DOCTOR AND TAKE PICTURES OF THE ORIGINAL IMPLANT. WHEN INTERVIEWING THE PHYSICIAN PRIOR TO BEGINNING THE REVISION SURGERY ON (B)(6) 2022, THE CAUSE OF THE GLENOSPHERE BECOMING DETACHED WAS UNKNOWN, BUT PHYSICIAN MENTIONED THE PATIENT HAD A BIG HEMATOMA AFTER THE INITIAL SURGERY, WHICH COULD HAVE CONTRIBUTED TO THIS. DURING SURGERY, THE GLENOSPHERE WAS RETRIEVED, THOROUGHLY CLEANED ON THE BACK TABLE, AND INVESTIGATED FOR ANY DAMAGE. IT WAS NOTED THAT THERE WAS A RING MARKING PRESENT ON THE BACKSIDE OF THE GLENOSPHERE. PHYSICIAN EXAMINED THE BASEPLATE TO SEE IF ANY DEFECTS WERE PRESENT ON THE MALE SIDE OF THE TAPER, AND NO VISIBLE DEFECTS WERE NOTED. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT THE POSTERIOR LOCKING SCREW WAS SITTING PROUD TO THE BASEPLATE SURFACE. ALTHOUGH DIFFICULT TO KNOW THE EXACT DISTANCE THE SCREW (SHOWN IN FIGURE 1) WAS SITTING PROUD, THE PHYSICIAN BELIEVED THIS COULD BE BLOCKING THE TAPER ENGAGEMENT, THUS DROVE IN THE SCREW FURTHER TO ATTEMPT TO BE FLUSH WITH THE BASEPLATE SURFACE. REVISION CASE WAS SUCCESSFULLY COMPLETED, AND PHYSICIAN WAS OVERALL HAPPY WITH THE OUTCOME OF THE CASE. THE RING NOTICED ON THE GLENOSPHERE (FIGURE 2) WAS LIKELY CAUSED BY THE SPHERE ROTATING AND RUBBING AGAINST THE SCREW THAT WAS PROUD PRIOR TO IT COMPLETELY DISLODGING. IT WAS DISCUSSED WITH THE PHYSICIAN THAT THE TAPER WAS LIKELY NOT FULLY SEATED IN THE INITIAL SURGERY, AGAIN DUE TO THE SCREW SITTING PROUD. THE PATIENT ADDITIONALLY HAD A LONG HISTORY OF SHOULDER SURGERIES AND HAS TYPICALLY BEEN UNCOMPLIANT TO POST-OP PROTOCOLS. ROOT CAUSE OF THE GLENOSPHERE DISSOCIATION WAS NOT FULLY TIGHTENING THE BASEPLATE SCREW, PREVENTING THE SPHERE FROM ENGAGING THE TAPER FULLY; THOUGH, THE PHYSICIAN SPECULATED THAT OTHER PATIENT FACTORS, INCLUDING NONCOMPLIANCE, AND A LARGE POSTOPERATIVE HEMATOMA, COULD HAVE PLAYED A ROLE IN THE DISSOCIATION EVENT. BECAUSE THE SCREW IS A LOCKING SCREW, IT IS UNLIKELY THAT THE SCREW BACKED OUT AFTER THE INITIAL PLACEMENT OF THE DEVICE, CAUSING THE SPHERE TO DISSOCIATE.

    Description of Event or Problem · 0

    AFTER A FOLLOW-UP VISIT WITH THE PATIENT, DOCTOR COMMUNICATED TO RESTOR3D ON (B)(6) 2022 THAT THE GLENOSPHERE COMPONENT OF THE CUSTOM RTSA (REVERSE TOTAL SHOULDER ARTHROPLASTY) PROSTHESIS DISENGAGED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, IN WHICH THE DOCTOR SUCCESSFULLY PUT THE ORIGINAL SPHERE BACK ON. DURING THIS SURGERY, IT WAS DISCOVERED THAT THE COMPONENTS NEVER ENGAGED DURING THE FIRST SURGERY AS A SCREW WAS SITTING PROUD, PREVENTING THE GLENOSPHERE FROM SEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472351 RESTOR3D PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT PHX RESTOR3D 9000-0057-B 20220911-DMP-C-01

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention