S-ROM 1365-26-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295033226), received between Aug 31, 2017 and Mar 12, 2025 — classified as 33 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (7 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT CAME INTO THE ER AT HOSPITAL WITH ACUTE HIP PAIN. EXAMINATION AND STUDIES INDICATED THIS PATIENT HAD AN INFECTED LEFT HIP. HIP WAS REPLACED APPROXIMATELY 10 YEARS AGO WHERE SHE HAD A SROM PINNACLE CONSTRUCT. THE EXACT DATE OF SURGERY IS UNKNOWN. SURGEON DID A THOROUGH I&D AND EXPLANTED THE PATIENTS METAL FEMORAL HEAD, HOLE ELIMINATOR, AND ULTAMET METAL LINER. THE SROM STEM, SLEEVE, AND CUP WERE LEFT IN SITU. A NEW FEMORAL HEAD AND POLY LINER WAS IMPLANTED. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21584540 ↗
• InjuryJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT FELL AT HOME AND DISLOCATED RIGHT HIP. SURGEON CHANGED HIP POLY TO CONSTRAINED LINER AND NEW HEAD. HIP WAS STABLE AND THERE WAS NO SURGICAL DELAYS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Dislocation; Joint Laxity

  MAUDE report 19447059 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: -THERE WAS A SURGICAL DELAY IN THAT THE CASE HAD TO BE PREFORMED IN ORDER TO REMOVE THESE ITEMS AND REIMPLANT . -THE ADVERSE CONSEQUENCES TO THE PATIENT IS THAT THEY HAD TO UNDERGO REVISION SURGERY IN LESS THAN 2 YEARS AFTER THE INITIAL SURGERY.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 18984282 ↗
• InjuryJul 26, 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: RIGHT HIP. THIS PC IS BILATERAL HIP ARTHROPLASTY LINKED TO (B)(4) LEFT HIP ARTHROPLASTY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17397065 ↗
• InjuryJul 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. THE SURGEON REMOVED THE HEAD AND IMPLANTED A +3. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6 ) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17325110 ↗
• MalfunctionJul 27, 2021Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS WAS A PRIMARY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229428 ↗
• InjuryJul 23, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS HAVING SOME PAIN IN THEIR HIP. THOUGHT THE HEAD WAS WEARING THROUGH THE POLY. UPON EXAMINATION, THE HEAD WAS WEARING ON THE SIDE OF THE POLY. THE S ROM 18X13X160 30 STD STEM WAS REMOVED AND VERSION WAS CHANGED IN THE STEM. SURGEON WOULD LIKE TO HAVE POLY EXAMINED TO SEE IF ANY MANUFACTURES ISSUES. DOI: (B)(6) 2017, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10314617 ↗
• InjuryApr 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REVISION DUE TO PAIN AND INSTABILITY. NO ADDITIONAL INFORMATION. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9995668 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. WASHOUT, NEW HEAD IMPLANTED. NO FURTHER INFORMATION AVAILABLE. DOI: (B)(6) 2020. DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9759025 ↗
• InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED INFECTED LEFT TOTAL HIP ARTHROPLASTY. OPERATIVE NOTES INDICATED PUS AROUND THE PROSTHESIS. HE HAS BEEN BACK ON 3 OCCASIONS FOR DRAINAGE AND IT WAS PURULENT. DOI: (B)(6) 2009; DOR: (B)(6) 2009 (LEFT HIP).

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 9664819 ↗
• InjuryNov 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD RECURRING HIP DISLOCATION. NO INFECTION. DOCTOR REPLACED LINER AND HEAD BALL. PLEASE SEND REPLACEMENTS TO (B)(6). DOI: (B)(6) 2008. DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9266044 ↗
• InjuryOct 28, 2019Naturally Worn; Naturally Worn

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES METAL WEAR AND METALLOSIS, AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO PAIN AND LIMITATIONS IN BILATERAL HIPS. OPERATIVE NOTES STATED THAT THERE WAS A BLOWOUT IN THE POSTERIOR REPAIR WITH A SIGNS OF METAL-ON-METAL DISEASE. BROWN-GREEN STAINING, RIGOROUS SHAPE, APPEARED VERY INTESTINAL. THERE WAS NO CLEAR ALTR. THE PATIENT WAS SIGNIFICANTLY SCARRED WITH HETEROTROPIC BONE ANTERIOR FEMUR, ANTERIOR ACETABULUM WITH THICK SCARRING IN SOME PACES AS MUCH AS 2-3 CM THICK. DOI: (B)(6) 2008; DOR: (B)(6) 2012; LEFT HIP. THE PATIENT HAS BILATERAL HIP IMPLANTS, PLEASE SEE (B)(4) FOR THE RIGHT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9244875 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SAID THE PATIENT HAD THEIR HIP DONE BY ANOTHER SURGEON ON (B)(6) 2008 AT (B)(6). THE PATIENT WAS DEVELOPING STIFFNESS IN THEIR HIP, AND ASKED THE SURGEON TO TAKE A LOOK. THE SURGEON NOTICED THE PATIENTS HIP PROSTHESIS WAS THAT OF A DEPUY METAL ON METAL. WHEN REVISING THE HIP, A RELATIVELY LARGE MASS OF DARK TISSUE WAS REMOVED FROM THE HIP DUE TO METALLOSIS. THE SURGEON REMOVED THE METAL LINER FROM THE PINNACLE CUP, WASHED OUT THE HIP, AND IMPLANTED A 50X32 NEUTRAL LINER. TRIAL REDUCTION WAS PERFORMED WITH A 32 +0 HEAD AND FOUND TO BE SATISFACTORY. REAL IMPLANT WAS OPENED AND IMPLANTED. CLOSING PROCESS BEGAN. DOI: (B)(6) 2008; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9220025 ↗
• InjuryAug 22, 2019Naturally Worn; Naturally Worn

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2006 - DOR: (B)(6) 2016, (LEFT HIP).

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Test Result

  MAUDE report 8921546 ↗
• InjuryAug 22, 2019Naturally Worn; Naturally Worn

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. LINER WAS NON DEPUY. DOI: (B)(6) 2013 - DOR: NONE REPORTED (RIGHT HIP)

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Test Result

  MAUDE report 8920970 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. A 36X50 METAL LINER AND 36-3 S-ROM COCR HEAD REMOVED AND REPLACED WITH A 32X50 NEUTRAL POLYETHYLENE LINER AND A 32+3 S-ROM CERAMIC HEAD. DOI: (B)(6) 2009; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8613192 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS. (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 8544532 ↗
• InjuryJan 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ELEVATED METAL IONS.

  Patient problems: Test Result

  MAUDE report 8265181 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS BEFORE FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8242156 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGED INJURY, PAIN, SUFFERING, SWELLING, TISSUE DAMAGE, SYNOVIAL FLUID BUILDUP, METALLOSIS, LACK OF MOBILITY, AND EMOTIONAL DISTRESS.

  Patient problems: Injury; Limited Mobility Of The Implanted Joint; Pain; Swelling; Tissue Damage

  MAUDE report 8171689 ↗
• InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS GOING TO DO A HIP WASH OUT ON A PATIENT THAT CAME INTO THE ER WITH A PAINFUL HIP. THE SURGEON SAID HE THOUGHT THAT THERE WAS AN INFECTION SO HE DID A THOROUGH I&D AND REPLACE THE HIP BALL ON A SROM STEM AND CHANGED A LINER IN A PINNACLE CUP.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 8054783 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PSEUDOTUMOR AND ELEVATED METAL IONS AFTER FIRST REVISION.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 7996998 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7995851 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS INTRACTABLE POST OPERATIVE PAIN. DOI: (B)(6) 2008; DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Pain

  MAUDE report 7951130 ↗
• InjuryOct 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT ALLEGES EXPERIENCING SEVERE PAIN, DISCOMFORT, AND INFLAMMATION IN HER LEFT THIGH AND GROIN. PATIENT ALSO EXPERIENCED PAIN AND DISCOMFORT WHENEVER MOVING TO AND FROM A SITTING POSITION AND WHEN STANDING. SHE CANNOT WALK WITHOUT A CANE AND HAS A LIMP. PATIENT HAS THE SENSATION THAT HER LEFT LEG IS WEAK AND THAT HER HIP WILL GIVE OUT ON HER. FRICTION AND WEAR BETWEEN METAL HEAD AND METAL LINER CAUSED LARGE AMOUNTS OF COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENT'S BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. PATIENT WILL LIKELY UNDERGO REVISION SURGERY TO REPLACE THE PINNACLE DEVICE. DOI: (B)(6) 2008 (LEFT SIDE); DOR: N/I.

  Patient problems: Discomfort; Inflammation; Pain; Test Result; Weakness

  MAUDE report 7934743 ↗