UNKNOWN TORNIER PERFORM IMPLANT
Received Jul 22, 2026 · Event occurred Jan 1, 2025
Report 0001649390-2026-00735 · MDR key 25904177
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented
Manufacturer
Tornier IncCatalog number
UNK_WTB
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. 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.
Description of Event or Problem
THE MANUFACTURER RECEIVED INVESTIGATOR INITIATED STUDY (IIS) NAMED "RADIOGRAPHIC STRESS SHIELDING OF INLAY VERSUS ONLAY HUMERAL STEMS FOLLOWING REVERSE TOTAL SHOULDER ARTHROPLASTY: A MULTICENTER STUDY" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PERFORM STEM AND TORNIER FLEX. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN 2018 AND 2025 DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: 5 CASES OF ACROMIAL STRESS FRACTURES IN THE INLAY COHORT THIS IS PATIENT 5 OUT OF 5.