MAUDE Adverse Event Report:; ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ10X108MM

Catalog Number 530-10-108

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Bone Shedding Debris (4557)

Event Type  Injury  

Manufacturer Narrative

Corrected data: original initial report was submitted as follow up in error.

Event Description

Revision surgery - the patient disassociated the attempt to cement 2 of the +8 spacers.This is the second revision for this patient in an effort to stabilize shoulder mechanics.The first implantation of a djo reverse components was a revision of a cement spacer to eradicate an infection received.The extreme amount of bone loss on both the humeral and glenoid was significant.Then the new index djo revision case, the patient dislocated the construct and had to be brought back to the operating room.To avoid explanting a well fixed humeral stem, the surgeon decided to attempt to bond 2 +8 spacers together with bone cement.This construct lasted approximately 6 months.All components, except the glenoid baseplate and locking screws, were removed during the revision surgery.This was a very complex case with multiple issues.During the implantation of the 44 +8 glenosphere, the screws fractured and a portion of the threads were unable to be retrieved.

• Type of Device: ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ10X108MM
• MDR Report Key: 11819607
• MDR Text Key: 250591729
• Report Number: 1644408-2018-00212
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 12/01/2020

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 Operator: No Information
• Device Catalogue Number: 530-10-108
• Device Lot Number: 409T1241
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention