SMS STEM

Description of Event or Problem

REVISION SURGERY DUE TO A PERIPROSTHETIC FRACTURE AFTER ABOUT 2 YEARS AND 2 MONTHS FROM PRIMARY SURGERY. THE SURGEON CABLED THE FRACTURE AND REVISED THE MEDACTA HEAD AND STEM TO A COMPETITOR HEAD AND STEM. THE SURGEON ALSO REVISED THE D 36/E HOODED PE HC LINER TO A D 36/E FLAT PE HC LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 01 JULY 2026: LOT 2248974: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APR-2023. EXPIRATION DATE: 2028-MAR-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. THE AVAILABLE CLINICAL INFORMATION DOES NOT INDICATE TRAUMA AND THE RELEVANT X-RAYS WERE NOT AVAILABLE FOR REVIEW. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.