S-ROM 1365-32-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 10603295033387), received between Mar 14, 2013 and Sep 11, 2026 — classified as 134 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (41 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 25 most recent of 137 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Device Dislodged or Dislocated

  It was reported that patient was revision due to dislocation.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Left Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50734465 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had infected hip. Washout/I&D was performed. Head and poly were swapped.Affected side- Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50452562 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient had infected hip. Washout/I&D was performed. Head and poly were swapped.Affected side-Left.

  Patient problems: Unspecified Infection

  MAUDE report 50452395 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ACETABULUM NEEDED TO BE REVISED. DOI: (B)(6) 2017. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 25461885 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION. ALL IMPLANTS REMOVED AND ANTIBIOTIC SPACER IMPLANTED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24790179 ↗
• InjuryMar 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED FROM METAL ON METAL PINNACLE TO CONSTRAINED LINER DUE TO DISLOCATIONS. DOI: (B)(6) 2007. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 24629992 ↗
• InjuryAug 8, 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 INSTABILITY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22751630 ↗
• InjuryAug 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO 3 DISLOCATIONS. HEAD & LINER EXCHANGE PERFORMED. DOI: (B)(6) 2009. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22715333 ↗
• InjuryAug 1, 2025Naturally Worn; Naturally Worn

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE PINNACLE HEAD AND LINER WERE REVISED FOR METAL-ON-METAL WEAR CAUSING A REACTION. THE HEAD SHOWS CORROSION. THE LINER SHOWS SEVERE FRETTING AND CORROSION ALONG WITH WEAR.

  Patient problems: Insufficient Information

  MAUDE report 22685663 ↗
• InjuryJun 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATION FROM PRIOR SURGERY. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22359285 ↗
• InjuryOct 31, 2024Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE S-ROM STEM AND SLEEVE WERE NOT REVISED IN BOTH CASES. JUST THE HEAD AND PINNACLE METAL LINERS.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 20582252 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENTS LEFT HIP WAS REVISED DUE ON (B)(6) 2024 DUE TO METAL ON METAL LINER EXPLANTED FOR OSTEOLYSIS. UNKNOWN SURGICAL DELAY. DATE OF IMPLANT IS UNKNOWN.

  Patient problems: Osteolysis

  MAUDE report 20526542 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A KNOWN INFECTION. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) WITH HEAD & LINER EXCHANGE. NO DELAYS, NO HARM DONE, NO ADVERSE CONSEQUENCES, NO BROKEN INSTRUMENTS OR IMPLANTS. DOI: (B)(6), 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20269045 ↗
• InjuryJul 26, 2024Degraded; Device Dislodged or Dislocated; Naturally Worn; Degraded; Device Dislodged or Dislocated; Naturally Worn

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2024. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO DISLOCATION, INSTABILITY, METAL WEAR, PAIN, IMPLANT LOOSENING, AND SUBSIDENCE -UNKNOWN IMPLANT(S). AT REVISION CORROSION WAS NOTED ON THE FEMORAL HEAD. DOI: (B)(6) 2007. DOE: 26-FEB-2024.

  Patient problems: Joint Dislocation; Joint Laxity; Pain

  MAUDE report 19843193 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INSTABILITY. THERE WAS NO DELAYS AND NO HARM TO THE PATIENT. DOI: UNKNOWN. DOR: (B)(4) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 18763105 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN FROM PREVIOUS HEAD AND LINER EXCHANGE. SURGEON REMOVED HEAD AND LINER, CONDUCTED A WASHOUT AND REPLACED WITH THE SAME HEAD AND LINER AS PREVIOUSLY USED. DOI: (B)(6) 2023. DOR: JANUARY 14, 2024. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18534162 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN IN HIP. THE 36 PLUS 3 METAL SROM HEAD AND A PINNACLE M.O.M. LINER WERE REMOVED AND REPLACED WITH A POLY LINER AND NEW SROM HEAD. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18310967 ↗
• InjuryOct 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATING RIGHT HIP. CHANGED HEAD AND LINER TO CONSTRAINED. NO OTHER INFO AVAILABLE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2023. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18038410 ↗
• InjurySep 28, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD RECEIVED. ON (B)(6) 2023, THE PATIENT HAD A REVISION RIGHT TOTAL HIP TO ADDRESS PAIN, SWELLING, AND BEARING WEAR. THE PATIENT WAS NOTED TO HAVE HAD A PREVIOUS METAL ON METAL HIP ARTHROPLASTY COMPLETED ON (B)(6) 2006. DURING THE CURRENT REVISION THE SURGEON OBSERVED BLUE-BLACK SYNOVIAL FLUID, COMPATIBLE WITH METALLOSIS. THE SURGEON ALSO NOTED AN ANTEROSUPERIOR CYST WHICH WAS DEBRIDED. THERE WAS CONSIDERABLE BACKSIDE SYNOVIAL FOREIGN BODY METALLOSIS REACTION NOTED. METAL HEAD AND LINER WERE REMOVED AND REPLACED WITH CERAMIC HEAD AND POLY LINER. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE.

  Patient problems: Cyst(s); Foreign Body Reaction; Pain; Swelling/ Edema

  MAUDE report 17833520 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT (I&D) WITH LINER AND HEAD EXCHANGE. THE 52X36 +4 10 DEGREE LINER AND 36 +3 METAL HEAD WERE REMOVED AND REPLACED WITH THE SAME SIZES. THERE WERE NO DELAYS OR ADVERSE EVENTS. DOI: UNKNOWN. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17623330 ↗
• InjuryAug 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LINER AND HEAD WERE REVISED FOR CHRONIC DISLOCATION. DOI: (B)(6) 2021. 1ST DOE: (B)(6) 2022. 2ND DOE: (B)(6) 2023. AFFECTED SIDE: LEFT HIP. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17563952 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2007, PATIENT RECEIVED A RIGHT TOTAL HIP REPLACEMENT USING S-ROM STEM AND PINNACLE CUP WITH METAL-ON-METAL ARTICULATION, TO ADDRESS END STAGE OSTEOARTHRITIS. THERE WAS NO REPORTED SURGICAL COMPLICATION. ON (B)(6) 2013, PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS ACUTE INFECTION. IRRIGATION AND DEBRIDEMENT WAS PERFORMED, WITH EXCHANGE OF ACETABULAR LINER AND FEMORAL HEAD. THERE WAS NO EVIDENCE OF METALLOSIS IDENTIFIED. THERE WAS EVIDENCE OF CORROSION ON THE STEM TRUNNION. THE CUP, HOLE ELIMINATOR, AND S-ROM STEM WITH SLEEVE WERE RETAINED. THERE WAS NO EVIDENCE OF OSTEOMYELITIS. ON (B)(6) 2023, PATIENT RECEIVED AN MRI OF THE RIGHT HIP. NO FINDINGS TO SUGGEST LOOSENING OF THE COMPONENTS OF THE RIGHT HIP IMPLANTS. OBSERVED 2 CM X 6 CM COMPLEX FLUID SIGNAL INTENSITY COLLECTION ALONG THE POSTERIOR MARGIN OF THE HIP JOINT AND PROXIMAL FEMUR. THIS COLLECTION COMMUNICATES WITH A DEFECT IN THE POSTERIOR PSEUDO CAPSULE AS WELL AS ABUTTING A CORTICAL DEFECT IN THE POSTERIOR ASPECT OF THE GREATER TROCHANTER. APPEARANCE SUGGEST ADVERSE TISSUE REACTION. IN THE APPROPRIATE CLINICAL CONTEXT INFECTION COULD HAVE A SIMILAR IMAGING APPEARANCE. CONSIDER ASPIRATION OF THE COLLECTION AND ANALYSI

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17057983 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT HEAD/LINER EXCHANGE FOR INFECTION. NO SURGICAL DELAY WAS THERE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17022551 ↗
• InjuryApr 17, 2023Adverse 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) 2023. AFFECTED SIDE- LEFT HIP.

  Patient problems: Pain

  MAUDE report 16753115 ↗
• InjuryFeb 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 16301915 ↗