S-ROM 1365-36-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295033547), received between Aug 3, 2017 and Jul 27, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  The patient was revised due to ongoing infection washout and removal of Emphasys DM liner and head construct consisting of an s-rom head and emphasys mb head. Replacing with the same components. No more information known.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50045929 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR MASS/TUMOR REMOVAL. HEAD/LINER REMOVAL WAS PERFORMED. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24766762 ↗
• InjuryDec 16, 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 INFECTION, HEAD/LINER EXCHANGE. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23815347 ↗
• InjuryMay 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAS AN ACETABULAR REVISION IN 2016. HE HAD A FEW DISLOCATIONS. HE WAS BROUGHT TO SURGERY FOR HEAD AND LINER SWAP 1221. DOI: (B)(6) 2016, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22090476 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NEW ONSET SYMPTOMS PLUS MINOR METALLOSIS SEEN AROUND THE TRUNION AND HEAD. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 20566419 ↗
• InjuryJun 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED FOR DISLOCATION. THE STRYKER CUP IS IN PLACE. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17058296 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2022 DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16213952 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN UNSTABLE HIP. SURGEON REMOVED LINER AND HEAD AND REPLACED WITH A CONSTRAINED LINER AND NEW RING AND HEAD. THIS WAS REVISED LAST YEAR (B)(6) 2020. DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Joint Laxity

  MAUDE report 11797573 ↗
• InjuryDec 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION SEVERAL TIMES, SWAPPED POLY TO CONSTRAINED LINER. DOI: UNKNOWN; DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 10945226 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS STEM BECAME UNSTABLE AND NEEDED TO BE REVISED. DOI: UNKNOWN, DOR: (B)(6) 2020 RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10852726 ↗
• InjuryFeb 5, 2020Naturally Worn; Naturally Worn

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FAILED RIGHT HIP ARTHROPLASTY, ADVERSE LOCAL TISSUE RESPONSE SECONDARY TO METAL DEBRIS AND TROCANTERIC FRACTURE. PRIOR TO REVISION PATIENT ALLEGED PAIN ,AND INJURY. OPERATIVE NOTES INDICATED UPON ENTERING THE HIP, THERE WAS OBVIOUS DESTRUCTIVE LESION OCCURRING. UPON ENTERING THE JOINT SPACE UNDER PRESSURE WAS THIS METAL STAINED FIBER PURULENT EXUDATE, A VERY THICK GRANULAR TYPE OF TISSUE THAT WAS DESTRUCTIVE IN NATURE. THERE WERE PERIPHERAL OSTEOLYTIC LESIONS. THE ACETABULAR COMPONENT WAS WELL FIXED ALSO WITH THE STEM. THERE WAS SOME MILD DEGREE OF TRUNNION WHERE NOTED. LAB RESULT FOR CHROMIUM WAS ABOVE 7. DOI: (B)(6) 2009; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Foreign Body Reaction; Injury; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 9670884 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ORIGINALLY HAD AN S-ROM FEMUR WITH A PINNACLE METAL ON METAL . THE METAL ON METAL WAS REVISED AND REPLACED IN 2010 BUT THE PATIENTS SYMPTOMS CONTINUED. THE PATIENT WAS REVISED TODAY TO REMOVE THE S- ROM STEM AND REPLACE IT WITH A NON MODULAR FEMORAL IMPLANT. A STEM WAS PLACED WITH A CERAMIC A 40MM CERAMIC HEAD AND 40MM ALTREX LINER. DOI: (B)(6) 2010 (HEAD AND LINER); STEM- UNKNOWN DOI; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9483385 ↗
• InjuryOct 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION. DOI: (B)(6) 2010; DOR: NONE REPORTED (LEFT HIP). THIS PC IS FOR THE ALLEGATIONS AFTER FIRST REVISION OF THE LEFT HIP. SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 9192919 ↗
• InjuryApr 17, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES ELEVATED METAL ION LEVELS AFTER THE FIRST REVISION SURGERY.

  Patient problems: Test Result

  MAUDE report 8522558 ↗
• InjuryMar 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS CUP LOOSENING AND A BROKEN SCREW. RETRIEVING THE SCREW DELAYED SURGERY ONE HOUR. UPDATE AD 10 JUL 2018: PPF ALLEGES, LOOSENING OF THE CUP, DISLOCATION AND INFECTION AFTER FIRST REVISION.

  Patient problems: Joint Dislocation; No Code Available; Unspecified Infection

  MAUDE report 8424548 ↗
• InjuryFeb 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION AFTER FIRST REVISION. IT WAS ALSO INDICATED THE CUP. LINER AND HEAD WERE REVISED.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8297365 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SWAPPED LINER AND HEAD. DOI: (B)(6) 2018; DOR: NOV 25, 2018; LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 8178323 ↗
• InjurySep 5, 2018Naturally Worn; Naturally Worn

  LITIGATION ALLEGES FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED LARGE AMOUNTS OF TOXIC METAL IONS AND PARTICLES RELEASED IN THE BLOOD, TISSUE AND BONE SURROUNDING THE IMPLANT. IT ALSO ALLEGES THAT THE PLAINTIFF EXPERIENCED INJURY, PAIN, DISCOMFORT, LOSS OF MOBILITY, LOSS OF RANGE OF MOTION, AND EMOTIONAL DISTRESS. THE SURGEON NOTED PRESENCE OF PSEUDOTUMOR, AND BLOOD WORK SHOWED ELEVATED LEVELS OF METAL IONS PRIOR TO THE REMOVAL OF THE PROSTHESIS. DOI: (B)(6) 2011 - DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Discomfort; Distress; Host-Tissue Reaction; Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Not Applicable; Pain; Test Result; Tissue Damage

  MAUDE report 7846081 ↗
• InjuryAug 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF ALLEGES INFECTION REQUIRING INTRAVENOUS ANTIBIOTICS AFTER FIRST REVISION. DOI: (B)(6) 2009- DOR: UNKNOWN (LEFT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 7801044 ↗
• InjuryNov 30, 2017Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND LEG LENGTH OFFSET REDUCTION. OPERATIVE NOTE REPORTED METALLOSIS WITH METAL STAINING OF SYNOVIAL TISSUES, CUP PLACEMENT WITH MINIMAL BONE WITH MALUNION CREATING ANTERIOR IMPINGEMENT. THE CUP WAS LEFT IN SITU TO PREVENT PELVIC DISCONTINUITY. SURGICAL PATHOLOGY REPORTED FIBROSYNOVIAL TISSUE WITH AGGREGATES OF HISTIOCYTES WITH YELLOW-BROWN METAL DEBRIS AND FOCAL MILD CHRONIC INFLAMMATION AND ALVAL. FIBROSIS DUE TO INTERNAL PROSTHETIC DEVICE. DOI: (B)(6) 2007; DOR: (B)(6) 2017; RIGHT HIP (SECOND REVISION).

  Patient problems: Arthritis; Fall; Fibrosis; Foreign Body Reaction; Host-Tissue Reaction; Inflammation; Joint Disorder; No Code Available; Pain; Synovitis; Weakness

  MAUDE report 7070159 ↗
• InjuryAug 3, 2017Metal Shedding Debris; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Metal Shedding Debris; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS PAIN AND A SMALL PSEUDO TUMOR.

  Patient problems: Discomfort; Host-Tissue Reaction; Inflammation; Pain

  MAUDE report 6764613 ↗