S-ROM 53-5362Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295172475), received between Aug 13, 2019 and Mar 31, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. THE SURGEON PERFORMED PATIENT'S INITIAL SURGERY IN (B)(6) OF 2020. THE PATIENT WAS IMPLANTED WITH A COMPETITOR ACETABULAR COMPONENT AND AUGMENT, BUT AN SROM STEM AND FEMORAL HEAD. THE STEM WAS UNFORTUNATELY LOOSE AND NEEDED TO BE REMOVED. DR. HAD TO PERFORM A FEMORAL SHORTENING IN THE PATIENT'S INITIAL SURGERY. UNFORTUNATELY, THE STEM DID NOT TAKE TO THIS PROCEDURE AND APPEARED TO BE LOOSE. WHAT REMAINED OF THE PATIENT'S PROXIMAL FEMUR WAS NOT IN THE BEST CONDITION EITHER, SO AFTER REMOVING THE SROM STEM AND SLEEVE, DR. OPTED TO PERFORM A PROXIMAL FEMORAL REPLACEMENT. DOI: (B)(6) 2020; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11595405 ↗
• MalfunctionAug 13, 2019Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE 16B REAMER DID NOT PREPARE THE FEMUR ADEQUATELY FOR THE 16B SPOUTLESS SLEEVE IMPLANT. THE REAMING WAS DONE TWICE, BUT THE SLEEVE STILL COULD NOT BE SEATED TO WHERE THE REAMER CLEARED. THE SLEEVE WAS LEFT PROUD BY ABOUT 5MM.

  Patient problems: Not Applicable

  MAUDE report 8889650 ↗