AEQUALIS REVERSED CUSTOM
Received Aug 10, 2016
Report 3004983210-2016-00029 · MDR key 5865482
Device
Generic name
Shoulder Joint Metal/metal Custom Prosthesis
Manufacturer
Tornier Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
27 YR
- Unspecified Infection
- Unspecified Infection
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: "INFECTION 2 MO LATER, MULTIPLE I&D WITH PROSTHETIC RETENTION" NO FURTHER PATIENT COMPLICATIONS OR SURGICAL DETAILS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.