SMR STEMLESS
Received May 14, 2026
Report 3008021110-2026-00235 · MDR key 25169165
Device
Product problems
- Patient Device Interaction Problem
Patient
NA · Unknown
- Metal Related Pathology
- Implant Pain
Narrative
Description of Event or Problem
REVISION SURGERY DUE TO POLYETHYLENE WEAR AND METALLOSIS, PERFORMED ON (B)(6) 2026. REMOVAL OF POLYETHYLENE DEBRIS AND ARTHROLYSIS AND IMPLANTATION OF A MODULAR INVERSE PROSTHESIS. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2017. THE COMPLAINT SOURCE REPORTED HUMERAL BONE DEFECTS AND LOOSENING OF THE STEMLESS CORE (CODE AND LOT NUMBER UNKNOWN) THIS EVENT OCCURRED IN GERMANY.
Additional Manufacturer Narrative
NO PRE-EXISTING ANOMALIES WERE DETECTED BY THE CHECK OF THE DEVICE HISTORY RECORDS OF THE LOT NUMBER INVOLVED (GLNEOSPHERE CODE 1374.50.440 LOT 1507280, STER. 1500173 - THIS PRODCUT CODE IS NOT CLEARED IN THE USA). THE PRODUCT INFORMATION OF THE STEMLESS CORE IS UNKNOWN THEREFORE PRODUCTION RECORDS REVIEW CANNOT BE PERFORMED. THIS IS THE FIRST AND ONLY COMPLAINT RECORDED ON LOT N. 1507280). A FINAL REPORT WILL BE SUBMITTED AFTER THE INVESTIGATION.