SMS Stem 01.36.053Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030888724), received between Apr 29, 2021 and May 12, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2023Migration; Migration

  AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. THE SURGEON REVISED THE HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16917559 ↗
• InjuryMay 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD SUFFERED AN INTRA-OP FRACTURE ON (B)(6) 2023. THE FEMUR FRACTURED WHEN IMPLANTING THE STEM (THE FRACTURE WAS BELOW THE DISTAL TIP OF THE STEM). THE SURGEON DECIDED TO HAVE THE PATIENT COME BACK TO REVISE THE STEM AND HEAD. ON (B)(6) 2023, THE PATIENT CAME IN AND HAD THE STEM AND HEAD REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD GOOD BONE QUALITY.

  Patient problems: Bone Fracture(s)

  MAUDE report 16917558 ↗
• InjuryApr 29, 2021Fracture

  1 WEEK AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A SPIRAL PERIPROSTHETIC FEMUR FRACTURE WHICH OCCURRED WHEN THE PATIENT WENT TO SIT DOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON DID NOT FEEL A NEED TO REVISE THE LINER.

  Patient problems: Bone Fracture(s)

  MAUDE report 11743644 ↗