S-ROM 1365-17-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295033158), received between Feb 1, 2018 and Oct 13, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 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.

• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO POLYETHYLENE WEAR. LEG LENGTH WAS SHORT. BOTH THE HEAD AND LINER WERE EXCHANGED. HEAD WAS INCREASED FROM A 28 +3 TO A 36+9. LINER CHANGED FROM 56 X 28 WITH +4 10 DEGREE TO 56 X 36 +4 10 DEGREE. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 10671564 ↗
• InjuryMay 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATING HIS HIP ON MULTIPLE OCCASIONS. THE SURGEON REVISED THE ACETABULAR COMPONENTS TO IMPROVE STABILITY. THE PINNACLE CUP WAS EXPLANTED AND A ZIMMER BIOMET CUP WAS IMPLANTED. THE S ROM STEM WAS LEFT IMPLANTED BUT THE HEAD WAS REVISED TO A 28MM +9 METAL S ROM COMPONENT. DOI: UNKNOWN. DOR: (B)(6) 2020. LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10080730 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND INFECTION. ANTIBIOTIC SPACERS WERE THEN IMPLANTED. RE-REVISION TO REMOVED THE SPACERS AND RE-IMPLANTATION OF DEFINITE IMPLANTS OCCURRED ON (B)(6) 2011. DOI: (B)(6) 2008 (CUP, SCREW, STEM, SLEEVE); DOI: (B)(6) 2010 (HEAD, LINER); DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9643399 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ABDUCTOR MUSCLE REPAIR. DOI: (B)(6) 2005; DOR: NONE REPORTED; LEFT HIP.

  Patient problems: Tissue Damage

  MAUDE report 9202167 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A GREATER TROCHANTER FRACTURE CAUSED BY OSTEOLYSIS. COBALT LEVELS WERE 1.9. ALL IMPLANTS WERE STILL WELL FIXED. THE DURALOC CUP WAS REMOVED AND REPLACED WITH A MUCH LARGER COMPETITOR CUP WITH A DUAL MOBILITY CONSTRUCT. THE STEM WAS LEFT AND A NEW HEAD WAS IMPLANTED. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN - DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable; Osteolysis

  MAUDE report 7864179 ↗
• InjuryFeb 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. SURGEON SAID THAT PATIENT HAS BEEN A CHRONIC DISLOCATOR SINCE 2012 AND PATIENT HAD A PRIOR REVISION 2 YEARS AGO. DOI: (B)(6) 2016; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7233590 ↗