S-ROM 55-0295Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295175162), received between Jan 21, 2020 and Sep 3, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER EXCHANGE DUE TO PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO FURTHER INFORMATION AVAILABLE. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT HIP.

  Patient problems: Pain

  MAUDE report 20128848 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER EXCHANGE DUE TO PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO FURTHER INFORMATION AVAILABLE. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT HIP.

  Patient problems: Pain

  MAUDE report 20128836 ↗
• InjuryApr 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO LOCKING PIN DISASSOCIATING. DOI: (B)(6) 2015 DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16742438 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 13977018 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 13976855 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL HIP TO ADDRESS POLYETHYLENE LINER WEAR DATE OF PRIMARY:(B)(6) 1983 (MANUFACTURER UNKNOWN). DATE OF REVISION #1: (B)(6) 1997. DATE OF REVISION #2: (B)(6) 2020. (RIGHT HIP). TREATMENT: FEMORAL HEAD AND ACETABULAR LINER REVISED.

  Patient problems: Discomfort; Loss of Range of Motion; Pain; Synovitis

  MAUDE report 12500705 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT HIP REVISION - ORIGINALLY SURGERY (B)(6) 2000. PATIENT DEVELOPED INSTABILITY AND WAS DISLOCATING. POLY WAS REPLACED WITH A CONSTRAINED LINER.

  Patient problems: Joint Laxity

  MAUDE report 11125453 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT THA PERFORMED OVER 20 YEARS AGO WITH NO INFORMATION AVAILABLE ABOUT THAT SURGERY. ON (B)(6) 2020. THE PATIENT HAD A RIGHT THA REVISION OF THE HEAD AND LINER FOR POLY WEAR REPORTED IN (B)(4). THE PATIENT RECEIVED A REREVISION TO TREAT PAIN SECONDARY TO TOO MUCH OFFSET AND LEG LENGTH. THIS NEW SURGEON WANTED TO REMOVED THE ENTIRE SROM CUP AND PUT IN A COMPETITOR DUAL MOBILITY AND NEEDED TO USE MY SROM 11/13 TAPER HEADS. THE SURGEON REMOVED THE METAL HEAD, POLY DIAL LINER AND LOCKING PINS, SCREW AND CUP. HE IMPLANTED A COMPETITOR DUAL MOBILITY HEAD AND USED MY 28MM +3 METAL SROM HEAD. HE WAS HAPPY WITH THE LEG LENGTHS AND OFFSET. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10752663 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT THA PERFORMED OVER 20 YEARS AGO WITH NO INFORMATION AVAILABLE ABOUT THAT SURGERY. ON (B)(6) 2020. THE PATIENT HAD A RIGHT THA REVISION OF THE HEAD AND LINER FOR POLY WEAR REPORTED IN (B)(4). THE PATIENT RECEIVED A REREVISION TO TREAT PAIN SECONDARY TO TOO MUCH OFFSET AND LEG LENGTH. THIS NEW SURGEON WANTED TO REMOVED THE ENTIRE SROM CUP AND PUT IN A COMPETITOR DUAL MOBILITY AND NEEDED TO USE MY SROM 11/13 TAPER HEADS. THE SURGEON REMOVED THE METAL HEAD, POLY DIAL LINER AND LOCKING PINS, SCREW AND CUP. HE IMPLANTED A COMPETITOR DUAL MOBILITY HEAD AND USED MY 28MM +3 METAL SROM HEAD. HE WAS HAPPY WITH THE LEG LENGTHS AND OFFSET. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10752622 ↗
• 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 9613552 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (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 9613549 ↗