S-ROM 87-5954Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295218845), received between Feb 26, 2019 and Nov 14, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 23561573 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD AND LINER WERE EXCHANGED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21332824 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INSTABILITY, THE SURGEON REMOVED 28+9 HEAD FROM SROM AND HAD A COMPETITOR'S CUP IN. ADDED A +4/10 FROM COMPETITOR AND PUT BACK IN A 32+9 HEAD. DOI: UNKNOWN DOR: (B)(6), 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 19143730 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. DOI- (B)(6), 2023. DOR- (B)(6), 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16531501 ↗
• InjuryJan 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO THE FEMORAL HEAD DISLOCATED, ONCE HEAD WAS REMOVED, SURGEON NOTICED CONSTRAINED LINER HAD BEEN CRACKED. REPLACED CONSTRAINED LINER AND IMPLANTED A 28+12 SROM HEAD. ORIGINAL IMPLANT DATE WAS UNKNOWN. IT WAS UNKNOWN IF ANY LOOSENING OCCURRED. THERE WAS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16115937 ↗
• InjuryDec 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ORIGINAL IMPLANT DATE UNKNOWN. PATIENTS HIP WAS DONE SEVERAL YEARS AGO BY DR (B)(6) AT (B)(6). DR (B)(6) WAS UNSURE OF THE EXACT DATE. PATIENT WAS DEALING WITH SOME DISLOCATION ISSUES. DR (B)(6) FELT THE PATIENT WOULD BENEFIT FROM A CONSTRAINED LINER. THE 56X28 +4/10 DEGREE LINER AND 28MM +9 HEAD WERE REMOVED. A +4 NEUTRAL CONSTRAINED LINER WAS TRIALED WITH A 36 +9 HEAD. HIP WAS FOUND TO BE STABLE AND THE REAL IMPLANTS WERE OPENED AND INSERTED. CLOSING PROCESS BEGAN. DOI: UNK, DOR: (B)(6) 2021 , RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13011388 ↗
• InjuryFeb 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD REVISION OF LEFT ACETABULUM DUE TO DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8370873 ↗