S-ROM 55-0235Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295175155), received between Jan 21, 2020 and Jun 6, 2024 — classified as 3 injuries.

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.

• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A WELL FUNCTIONING HIP THAT HAD BEEN PLACED APPROX 13 YEARS AGO PER SURGEON. PATIENT HAD A DENTAL PROCEDURE (B)(6) AND WOKE UP WITH HIP PAIN THE FOLLOWING DAY. CONTACTED WITH SURGEON AND WAS SCHEDULED FOR A HEAD AND LINER EXCHANGE AS SOON AS INSTRUMENTS AND IMPLANTS COULD BE AVAILABLE. HEAD, LINER AND LOCKING PINS WERE REMOVED AND REPLACED TO INCLUDE A THOROUGH IRRIGATION AND DEBRIDEMENT (I&D) AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO PATIENT HARM OCCURRED NOR DELAY WAS EXPERIENCED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 19477768 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A WELL FUNCTIONING HIP THAT HAD BEEN PLACED APPROX 13 YEARS AGO PER SURGEON. PATIENT HAD A DENTAL PROCEDURE MONDAY AND WOKE UP WITH HIP PAIN THE FOLLOWING DAY. CONTACTED WITH SURGEON AND WAS SCHEDULED FOR A HEAD AND LINER EXCHANGE AS SOON AS INSTRUMENTS AND IMPLANTS COULD BE AVAILABLE. HEAD, LINER AND LOCKING PINS WERE REMOVED AND REPLACED TO INCLUDE A THOROUGH IRRIGATION AND DEBRIDEMENT (I&D) AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO PATIENT HARM OCCURRED NOR DELAY WAS EXPERIENCED. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP

  Patient problems: Pain

  MAUDE report 19477608 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO LEFT PERIPROSTHETIC FRACTURE AND PERIPROSTHETIC INSTABILITY. DOI: 1997; DOR: (B)(6) 2018; (LEFT HIP). HEAD AND LINER REVISED.

  Patient problems: Hematoma; No Code Available; Pain

  MAUDE report 9613548 ↗