S-ROM 55-6074Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295175940), received between Jun 8, 2022 and Jul 22, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (3 reports).

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

• InjuryJul 22, 2025Osseointegration Problem; Osseointegration Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE CAUSE OF THE REVISION SURGERY. THIS PC REPORTS THE POOR FIT OF THE STEM FOUND DURING THE REVISION SURGERY. IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT UNDERWENT AN INITIAL SURGERY PERFORMED WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY ON (B)(6) 2025, A FEMORAL HEAD DISLOCATION WAS CONFIRMED. ON (B)(6) 2025, THE REVISION SURGERY WAS PERFORMED TO REPLACE THE LINER AND HEAD. DURING THE SURGERY, AN ACETABULAR CUP, POLO PRODUCT REPORTED ON (B)(4), LOOSENING WAS CONFIRMED AND THE CUP WAS REPLACED WITH A CEMENT CUP FROM OTHER COMPANY. WHEN THE HEAD WAS REPLACED WITH A NEW 9/10 TAPER HEAD, IT WAS FOUND THAT THE NECK TAPER WAS DISTORTED AND THERE WAS A POOR FIT, WHICH MAY HAVE BEEN THE CAUSE OF THE DISLOCATION, SO THE STEM WAS REMOVED AND REPLACED WITH A NEW CEMENTED STEM (C-STEM AMT). THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON CONCLUDED THAT THE REASON FOR THE CUP REVISION WAS THAT BLACK TISSUE HAD FORMED AT THE BOUNDARY SURFACE, WHICH HAD CAUSED BONE DISSOLUTION AND LOOSENING. THE REASON FOR THE STEM REVISION WAS THAT, JU

  Patient problems: Inadequate Osseointegration

  MAUDE report 22564621 ↗
• InjuryDec 8, 2022Naturally Worn; Osseointegration Problem; Naturally Worn; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF A COMPETITOR CUP AND DEPUY SCREWS AT THE BONE TO IMPLANT INTERFACE, WEAR OF THE SCREWS, ARMD, AND UNSPECIFIED SUBLUXATION OF THE STEM RESULTING IN JOINT INSTABILITY. DOI: (B)(6) 2008. DOR: (B)(6) 2022. UNKNOWN HIP.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Joint Laxity

  MAUDE report 15942331 ↗
• InjuryJun 8, 2022Fracture; Off-Label Use; Osseointegration Problem; Fracture; Off-Label Use; Osseointegration Problem

  IT WAS REPORTED THAT ON APRIL 9, 2007, THE PATIENT UNDERWENT A THA SURGERY FOR OA OF HIP. AFTER SURGERY, THE SCREWS BROKE DUE TO LOOSENING OF A CUP, AND THE PATIENT HAD PAIN. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED WITH NO SURGICAL DELAY. IN THE REVISION SURGERY, THE STEM WAS KEPT USING AS IT WAS, AND THE CUP WAS REPLACED. THE LOOSENED CUP IS A COMPETITOR¿S PRODUCT. THE SURGEON COMMENTED THAT THE CAUSE OF LOOSENING OF THE CUP MIGHT HAVE BEEN DUE TO ALVAL (ASEPTIC LYMPHOCYTIC VASCULITIS-RELATED LESION) SINCE THE IMPLANTS IMPLANTED IN A STATE OF MOM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Pain

  MAUDE report 14633732 ↗