MAUDE Adverse Event Report: RESTOR3D RESTOR3D; PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT

Model Number 9000-0057-B

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Implant Pain (4561)

Event Date 12/13/2022

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: RESTOR3D
• Type of Device: PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
• Manufacturer (Section D): RESTOR3D; 4001 nc hwy 54,; suite 2160; durham NC 27709
• Manufacturer (Section G): RESTOR3D; 4001 nc hwy 54,; suite 2160; durham NC 27709
• Manufacturer Contact: tiffany wu ; 4001 nc hwy 54,; suite 2160; durham, NC 27709 ; 9848880593
• MDR Report Key: 16142803
• MDR Text Key: 307165936
• Report Number: 3014833750-2023-00001
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 520(B) EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 12/24/2022
• Device Model Number: 9000-0057-B
• Device Catalogue Number: 9000-0057-B
• Device Lot Number: 20220911-DMP-C-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 72 KG