inforMED
InjuryKWR

AEQUALIS REVERSED CUSTOM

Received Aug 10, 2016

Report 3004983210-2016-00030 · MDR key 5865485

Device

Generic name

Shoulder Joint Metal/metal Custom Prosthesis

Manufacturer

Tornier Inc.

Product problems

  • Device Dislodged or Dislocated
  • Device Dislodged or Dislocated

Patient

41 YR

  • Failure of Implant
  • Fracture, Arm
  • Failure of Implant
  • Fracture, Arm

Narrative

Additional Manufacturer Narrative

THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. LITERATURE SOURCE: EARLY OUTCOMES FOLLOWING METAL-ON-METAL REVERSE TOTAL SHOULDER ARTHROPLASTY IN PATIENTS YOUNGER THAN 50 YEARS. CLAY RILEY, MD; JOHN IDOINE, DO; YOUSEF SHISHANI, MD; REUBEN GOBEZIE, MD; BRADLEY EDWARD S, MD. ORTHOPEDICS. 2016 JUN 23:1-5. HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/27337662.

Description of Event or Problem

IT WAS REPORTED IN THE LITERATURE: "GLENOID FRACTURE WITH BASEPLATE LOOSENING; BASEPLATE REMOVAL AND GLENOID BONE GRAFTING, THEN LATER REVISED" NO FURTHER PATIENT COMPLICATIONS OR SURGICAL DETAILS HAVE BEEN REPORTED.