S-ROM 1365-31-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 10603295033363), received between May 14, 2013 and Apr 20, 2026 — classified as 139 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (27 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 140 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF MOM LINER AND HEAD DUE TO PAIN AND METAL REACTION. DOI: (B)(6) 2007. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 24926890 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WANTED MORE LEG LENGTH. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 24674945 ↗
• InjuryJan 22, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED. SURGEON CONVERTED TO CONSTRAINED LINER. THERE WAS NO DELAY AND NO HARM DONE TO PATIENT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24145035 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND UNDERWENT MOM LINER REVISION DUE TO ELEVATED METAL ION LEVELS. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT HARM. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 21355322 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO SEVERE HO AND BECAUSE THE S ROM STEM HAD MIGRATED INTO VARUS ALIGNMENT. THE SURGEON PERIOD AN ETO TO REMOVE THE S ROM STEM, S ROM SLEEVE AND FEMORAL HEAD. HE PREPPED AND PLACED A COMPETITOR STEM FOR THE FEMUR. HE REMOVED THE 62MM X 36MM NEUTRAL PINNACLE LINER AND REPLACED IT WITH A 62MM X 40MM NEUTRAL PINNACLE LINER. CASE WAS COMPLETED WITHOUT ISSUES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Extraskeletal ossification

  MAUDE report 19554393 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER WERE EXCHANGED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Insufficient Information; Metal Related Pathology; Muscular Rigidity; Necrosis; Pain; Unspecified Tissue Injury

  MAUDE report 19333312 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO OSTEOLYSIS. DATE OF IMPLANT: (B)(6) 2004. DATE OF REVISION: (B)(6) 2024. (LEFT HIP). TREATMENT: HEAD, LINER, AND CUP WERE REVISED.

  Patient problems: Osteolysis

  MAUDE report 19231613 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR CARDIOVASCULAR COMPLICATIONS (E.G. MI). EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2005. DATE OF EVENT: 14 MAR 2024. (LEFT HIP). TREATMENT: NONE.

  Patient problems: Myocardial Infarction

  MAUDE report 19019632 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT THE PATIENT WAS REVISED DUE TO HIGH METAL ION LEVELS. DOCTOR REMOVED BOTH THE FEMORAL HEAD AND METAL LINER. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 17443481 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND WORSENING FUNCTION, ELEVATED COBALT AND CHROMIUM LEVELS. DOI: (B)(6) 2006. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP. THIS PC IS BILATERAL HIP ARTHROPLASTY LINKED TO (B)(4) RIGHT HIP ARTHROPLASTY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17406159 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INSTABILITY. NEW HEAD IMPLANTED. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17049088 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION TO REMOVE A METAL LINER FROM THE CUP DUE TO A REACTION TO THE ELEVATED IONS. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2007, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 16887838 ↗
• InjuryApr 11, 2023Noise, Audible; Noise, Audible

  CLINICAL ADVERSE EVENT RECEIVED FOR SQUEAKING. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2003, DATE OF EVENT: (B)(6) 2023 (LEFT HIP). TREATMENT: MRI TO DETERMINE FURTHER TREATMENT.

  Patient problems: Insufficient Information

  MAUDE report 16712939 ↗
• InjuryMar 16, 2023Naturally Worn; Naturally Worn

  MEDICAL RECORD RECEIVED. MEDICAL RECORDS REPORT SYNOVIUM AND SOFT TISSUE WITH DEGENERATIVE AND CHRONIC INFLAMMATORY CHANGES. PIGMENTED HISTIOCYTES ARE NOTED CONSISTENT WITH METALLOSIS ("DEPOSITION" OF METALLIC PARTICULATES). FRAGMENTS OF BONE AND CARTILAGE WITH DEGENERATIVE AND REACTIVE CHANGES. METALLOSIS NOTED. BONE MARROW WITH TRILINEAGE MATURING HEMATOPOIESIS. ALSO RECEIVED ARE TWO METALLIC, THREADED SCREWS MEASURING 2.7 AND 3.7 CM IN LENGTH.

  Patient problems: Adhesion(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16553837 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INSTABILITY. HEAD & LINER EXCHANGE PERFORMED.. DOI: (B)(6) 2005. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16428068 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. PATIENT HAD BILATERAL TOTAL SROM HIPS. SHE WAS REVISED DUE TO INFECTION IN BOTH HIPS. LOT NUMBER ON THE CUP WAS DAMAGED DURING EXPLANT AND UNRETRIEVABLE. THE R SIDE WAS CONVERTED TO A REVISION PINNACLE CUP FOR BETTER POSITIONING THE L SIDE WAS REVISED WITH HEAD AND LINER EXCHANGE. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 16101791 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE METAL HEAD ON METAL LINER LEAD TO METALLOSIS OF THE IMPLANTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2005, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 15606567 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO METAL ON METAL AND PAIN. DOI - UNKNOWN. DOR - (B)(6) 2022. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 13720493 ↗
• InjuryMar 8, 2022Naturally Worn; Naturally Worn

  REVISION COMPLETED TO ADDRESS SUSPECTED PSEUDOTUMOR AND METAL WEAR. DOI: (B)(6) 2009. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13693304 ↗
• InjuryJan 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLE REMOTE RELATION TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2008; DATE OF EVENT (ONSET): (B)(6) 2021 (LEFT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 13385154 ↗
• InjuryDec 14, 2021Degraded; Naturally Worn; Degraded; Naturally Worn

  PINNACLE LITIGATION RECORDS RECEIVED. PATIENT WAS REVISED WAS DUE TO HEAVY METAL POISONING. ALSO ALLEGES PAIN, INJURIES, METALLOSIS, METAL WEAR, LOSS OF MOBILITY, TISSUE DESTRUCTION, LIMITED DAILY ACTIVITIES, SCARRING AND DISFIGUREMENT. DOI: (B)(6) 2008, DOR: (B)(6) 2021, UNK HIP.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Deformity/ Disfigurement; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Necrosis; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 13005132 ↗
• InjurySep 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND IMPLANT RECORD RECEIVED. PATIENT HAD AN INFECTION AND DISLOCATION AFTER 1ST REVISION. DOI: (B)(6) 2011. DOR: (B)(6) 2017, (LEFT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation

  MAUDE report 12495741 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POLY WEAR AFTER ¿20+ YEARS¿ OF USAGE. DR. (B)(6) CHANGED THE HEAD AND POLY, WHICH HE USED THE CONSTRAINED LINER OPTION FOR MORE STABILITY. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNK, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 12398479 ↗
• InjuryApr 27, 2021Degraded; Naturally Worn; Degraded; Naturally Worn

  PINNACLE UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO MALFUNCTION OF MOM LEFT HIP ARTHROPLASTY RESULTING TO PAIN, ELEVATED COBALT AND CHROMIUM LEVEL AND MECHANICAL SENSATION LEFT THA. OPERATIVE NOTE REPORTED MILKY YELLOW FLUID COLLECTION CONSISTENT WITH ADVERSE LOCAL TISSUE REACTION WITH DARK STAINING OF THE CAPSULAR TISSUES AND SYNOVIUM. NOTICEABLE GROSS WEAR OF THE SUPERIOR ASPECT OF THE ACETABULAR LINER. SIGNIFICANT CORROSION NOTED AT THE LOCKING MECHANISM OF THE LINER AND THE SHELL. HOWEVER, MINIMAL CORROSION NOTED AT THE HEAD NECK TAPER JUNCTION. DOI: (B)(6) 2008; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Pain

  MAUDE report 11731547 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INDICATED THAT THE REASON FOR REVISION IS PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Pain

  MAUDE report 11719586 ↗