inforMED
InjuryKWR

AEQUALIS REVERSED CUSTOM

Received Aug 10, 2016

Report 3004983210-2016-00027 · MDR key 5865474

Device

Generic name

Shoulder Joint Metal/metal Custom Prosthesis

Manufacturer

Tornier Inc.

Product problems

  • Device Dislodged or Dislocated
  • Device Dislodged or Dislocated

Patient

27 YR

  • Failure of Implant
  • Failure of Implant

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

LITERATURE INDICATED: "DISLOCATED 1 Y POSTOP, REVISED" NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.