S-ROM 55-6073Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295175933), received between Oct 26, 2017 and Jul 8, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2007, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE PINNACLE DEVICES AND THE S-ROM IN QUESTION. ON (B)(6) 2022, THE REVISION SURGERY WAS PERFORMED BECAUSE THE CUP HAS SHIFTED DUE TO ARMD. THE SURGEON LEFT THE SLEEVE AND REPLACED THE CUP WITH ZB¿S CUP. THE SURGEON ALSO REPLACED THE STEM AND THE HEAD. DOI: (B)(6) 2007. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Foreign Body Reaction

  MAUDE report 14957037 ↗
• InjuryJun 8, 2022Fracture; Off-Label Use; Osseointegration Problem; Fracture; Off-Label Use; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 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 14633834 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOSPITAL´S PURCHASING DEPARTMENT IS ASKING FOR THE POSSIBILITY TO ORDER THIS PRODUCT AS A PATIENT SPECIFIC IMPLANT. THIS REQUEST IS ENTERED AS A COMPLAINT AS IT MIGHT BE RELATED TO A PLANNED REVISION.

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 9799457 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON BY REPLACING THE LINER AND THE HEAD DUE TO DULL PAIN IN AFFECTED AREA, FEMORAL NERVE PALSY, SUSPECTED ARMD.

  Patient problems: Nerve Damage; No Code Available; Pain; Tissue Damage

  MAUDE report 8314865 ↗
• InjuryDec 6, 2018Loss of Osseointegration; Loss of Osseointegration

  THIS REVISION HIP WAS FOR REVISION OF LOOSE ACETABULAR COMPONENT. OSTEOLYSIS PRESENT IN PROXIMAL.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 8137159 ↗
• InjuryOct 26, 2017Use of Device Problem; Loss of Osseointegration; Use of Device Problem; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAIN, METAL CORROSION WAS SEEN AROUND THE JUNCTION PART AND CUP LOOSENING. COMPETITOR CUP WAS USED.

  Patient problems: Pain

  MAUDE report 6980504 ↗