S-ROM 52-3207Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295170938), received between Sep 12, 2019 and Jul 8, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT ON (B)(6) 2003, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. IT IS UNKNOWN WHETHER THE IMPLANTS OTHER THAN REPORTED PRODUCTS USED IN THE PRIMARY SURGERY ARE JJ PRODUCTS OR NOT. ON AN UNKNOWN DATE, DISLOCATION AND STEM SINKING WERE CONFIRMED. THE CAUSE OF THE LOOSING WAS UNKNOWN. THEREFORE, THE REVISION SURGERY IS SCHEDULED FOR (B)(6) 2024, AT ANOTHER HOSPITAL. THE CUP SIDE IS ALSO POORLY PLACED, AND ALL IMPLANTS WILL BE REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19690340 ↗
• InjuryJun 19, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE AND LOOSE STEM. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 19568016 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISLOCATION INCURRED POST-OP. THE PATIENT WAS ADMITTED DUE TO BILATERAL HIP PAIN, AND PREOPERATIVE DIAGNOSIS WAS BILATERAL CONGENITAL HIP DYSPLASIA (CROWE IV TYPE ON THE RIGHT). AFTER THE SURGERY, THE PATIENT'S CONDITION RECOVERED AND WAS ABLE TO PERFORM WEIGHT-BEARING ACTIVITIES ON THE GROUND. ON THE TENTH DAY AFTER THE SURGERY, THE PATIENT ACCIDENTALLY SPRAINED WHILE PERFORMING WEIGHT-BEARING ACTIVITIES ON THE GROUND, FEELING SEVERE PAIN IN THE RIGHT HIP AND UNABLE TO MOVE THE RIGHT HIP. UPON PHYSICAL EXAMINATION, THERE WAS OBVIOUS SHORTENING AND ADDUCTION DEFORMITY IN THE RIGHT LOWER LIMB. DR EXAMINATION WAS PERFORMED TO CONFIRM THE DISLOCATION OF THE RIGHT HIP PROSTHESIS. OPEN REDUCTION SURGERY WAS PERFORMED UNDER ANESTHESIA IN THE OPERATING ROOM, AND BRACES WERE WORN AFTER THE SURGERY TO AVOID FURTHER DISLOCATION.

  Patient problems: Loss of Range of Motion; Pain; Physical Asymmetry; Unspecified Tissue Injury

  MAUDE report 17208330 ↗
• InjurySep 12, 2019Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THAT THE PATIENT'S FEMUR COMPONENTS SUBSIDED. SURGEON BELIEVED HE ORIGINALLY UNDERSIZED THEM. DOI: (B)(6) 2018, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9009385 ↗