UNKNOWN PYROCARBON HUMERAL HEAD
Received May 28, 2026 · Event occurred Jul 28, 2025
Report 3000931034-2026-00442 · MDR key 25313233
Device
Generic name
Shoulder Joint Humeral (hemi-shoulder) Ceramic Head/metallic Stem Cemented
Manufacturer
Tornier S.a.s.Catalog number
UNK_WTM
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Malunion of Bone
Narrative
Description of Event or Problem
THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE TEL AVIV SOURASKY MEDICAL CENTER. THE TITLE OF THIS REPORT IS "PYROLYTIC CARBON HEAD HEMIARTHROPLASTY VERSUS COBALT-CHROMIUM HEAD FOR PROXIMAL HUMERUS FRACTURES - A SHORT-TERM FOLLOW-UP STUDY", PUBLISHED ON 28 JULY 2025, WHICH IS ASSOCIATED WITH THE STRYKER TORNIER PYROCARBON HUMERAL HEAD AND TORNIER FLEX SYSTEM. THE ARTICLE CAN BE FOUND ON HTTPS://DOI.ORG/10.1016/J.JSE.2025.07.032 DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND AT THIS TIME NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT: 1 PATIENT EXPERIENCED GREATER TUBEROSITY MALUNION.
Additional Manufacturer Narrative
THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS IDENTIFIED DURING POST MARKET SURVEILLANCE LITERATURE. THE ARTICLE CAN BE FOUND AT TTPS://DOI.ORG/10.1016/J.JSE.2025.07.032. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.