S-ROM 87-5955Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295218852), received between Oct 13, 2017 and Nov 14, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED THEIR CONSTRAINED POLY. SURGEON REVISED IT TO A DUAL MOBILITY AND SWITCHED OUT THE HEAD. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23554878 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY; DOCTOR WENT TO A 40 HEAD. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23554721 ↗
• InjuryApr 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO A FALL AND DISLOCATED CONSTRAINED LINER. THE CONSTRAINING RING BROKE IN TWO PIECES. THE PATIENT HAD A PREVIOUS (2019) PELVIC FRACTURE WITH PLATE AND SCREW FIXATION AND A TOTAL HIP. HEAD AND LINER EXCHANGE WAS PERFORMED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 16806921 ↗
• InjuryMar 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO DISLOCATION AND STABILITY ISSUE. 48 CUP WAS REMOVED AND 52 CUP WAS IMPLANTED TO IMPROVE CUP POSITION AND ALSO TO GET FROM A 32 TO A 36 HEAD FOR ADDITIONAL STABILITY. NO ADDITIONAL INFORMATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 13685140 ↗
• InjuryDec 9, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD RECEIVED. LITIGATION ALLEGES THAT THE PATIENT WAS DIAGNOSED WITH DENSE FIBROUS TISSUE AND FOCAL SYNOVIUM WITH FOCI OF DEGENERATION, HEMORRHAGE, MILD CHRONIC LYMPHOHISTIOCYTIC INFLAMMATION, HEMOSIDEROSIS, METALLOSIS, RARE FOREIGN BODY GIANT CELLS, AND ABUNDANT FIBRIN OF THE RIGHT HIP BONE AND TISSUE. DOI: (B)(6) 2018, DOR: NOT REPORTED, RIGHT HIP. (B)(4).

  Patient problems: Foreign Body Reaction; Inflammation; Joint Dislocation; Necrosis; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10975925 ↗
• InjurySep 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HER HIP REPLACED IN 2007 BY DR. (B)(6), THE PATIENT DID WELL UNTIL RECENTLY WHEN SHE HAD DISLOCATED HER HIP MULTIPLE TIMES AND HAD TO HAVE IT REDUCED IN THE ER. THE EXACT DATE OF THE PRIMARY SURGERY IS UNKNOWN, THE EXACT DATES OF DISLOCATIONS ARE UNKNOWN. THE SURGEON EXPLANTED A 54 + 4 NEUTRAL MARATHON LINER AND A 32MM + 3 METAL SROM HIP BALL TO TREAT RECURRENT DISLOCATIONS AND JOINT INSTABILITY. A NEW 36MM + 4 10 DEGREE 54MM LINER AND A 36MM + 9 CERAMIC SROM HIP BALL WERE IMPLANTED. DOI: 2007. DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10547410 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 S-ROM HIP WAS PUT IN. THE PATIENT HAS HAD PAIN IN HIP. NOT SURE IF INFECTED. I&D WAS DONE AND PUT IMPLANTS BACK IN. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9145103 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND MEDICAL RECORDS RECEIVED. THERE WERE NO NEW ALLEGATION REPORTED FROM PPF. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS CHRONIC DISCOMFORT AND BURSITIS VERSUS ABDUCTOR TENDON TEARS BUT OPERATIVE NOTES REPORTED THAT ABDUCTOR TENDON APPEAR TO BE INTACT. REVISION NOTE REPORTED METALLOSIS AND THE POSTERIOR ASPECT OF THE FEMORAL NECK WAS IMPINGING ON THE RETAINING RING ON THE ACETABULAR COMPONENT. DOI: (B)(6) 2013; DOR: (B)(6) 2015 (LEFT HIP) THIRD REVISION. PLEASE SEE (B)(4) FOR THE FIRST REVISION. PLEASE SEE (B)(4) FOR THE SECOND REVISION.

  Patient problems: Discomfort; Foreign Body Reaction; No Code Available

  MAUDE report 9120574 ↗
• InjuryApr 29, 2019Biocompatibility; Device Dislodged or Dislocated; Biocompatibility; Device Dislodged or Dislocated

  PFS HAS NO NEW ALLEGATION. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESSED PAIN AND RECURRENT HIP INSTABILITY AND DISLOCATION AFTER FIRST REVISION. OPERATIVES NOTES INDICATED LINER SHOWED SOME DAMAGE FROM THE DISLOCATIONS. NO INFECTION REPORTED. DOI: (B)(6) 2017, DOR: (B)(6) 2017 RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Disorder; No Code Available; Pain; Test Result; Unspecified Infection

  MAUDE report 8559998 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS AFTER FIRST REVISION. LINER WAS NON METAL AND STEM WAS ALREADY REPORTED IN 1ST PC. (LEFT HIP).

  Patient problems: Test Result

  MAUDE report 8528699 ↗
• InjuryFeb 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF, STICKER SHEETS AND IMPLANT RECORDS RECEIVED. PPF ALLEGES FRACTURE (BONE) AND INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2012 - DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 8324959 ↗
• InjuryDec 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION ALLEGES DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8176751 ↗
• InjuryNov 16, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD SEVERAL RECENT DISLOCATIONS.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8080670 ↗
• InjurySep 17, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PPF, IMPLANT RECORDS AND STICKER SHEETS RECEIVED. THE PPF ALLEGES ELEVATED METAL IONS AFTER THE FIRST REVISION OF THE RIGHT HIP. ONLY THE HEAD WAS ADDED IN THE IMPACTED PRODUCTS AS THE LINER USED WAS POLYETHYLENE AND THE STEM WAS ALREADY IMPACTED IN THE OTHER PC. DOI: (B)(6) 2013; DOR: NONE REPORTED; (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 7882527 ↗
• InjuryAug 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DER STATES: DISLOCATION WAS THE REASON FOR THE REOPERATION. S-ROM STEM WITH A 52 MM ULTAMET LINER WITH A 36MM HEAD HAD PREVIOUSLY BEEN IMPLANTED. THE HEAD AND LINER WERE REMOVED AND A PINNACLE 52MM CONSTRAINED LINER WAS IMPLANTED AND IMPACTED INTO THE CUP. A +3 / 32MM HEAD WAS THEN IMPACTED ON TO THE S-ROM STEM, THE LOCKING RING WAS PLACED OVER THE HEAD AND RESTED ON THE TRUNION. HIP WAS REDUCED INTO THE CONSTRAINED LINER AND THE RING WAS PROPERLY SEATED AND GENTLY TAPPED INTO PLACE. SOME DARKISH GRAY SOFT TISSUE WAS REMOVED. DOI: UNKNOWN, DOR: (B)(6) 2018, UNKNOWN HIP.

  Patient problems: Joint Dislocation; Tissue Damage

  MAUDE report 7794624 ↗
• InjuryJun 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AND INFECTION. (B)(6) 2015 - DOR: NOT REPORTED (LEFT HIP). (B)(4). FIRST REVISION.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 7619871 ↗
• InjuryJun 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PINNACLE PPF RECEIVED. PPF ALLEGES STROKE AND HEART ATTACK. DOI: (B)(6) 2017; DOR: NOT REPORTED (LEFT HIP).

  Patient problems: Cardiac Arrest; Infarction, Cerebral; Injury; No Code Available

  MAUDE report 7597842 ↗
• InjuryJun 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available; Not Applicable

  MAUDE report 7572881 ↗
• InjuryJan 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PATIENT HAS BEEN DISLOCATING SO IT WAS DECIDED TO CHANGE HIM TO A CONSTRAINED LINER. HE WENT FROM A 32MM HEAD TO A 36 CONSTRAINED. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES. DOI: UNKNOWN; DOR: (B)(6) 2018, UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7214961 ↗
• InjuryOct 13, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. STEM WAS REVISED AND THE VERSION.

  Patient problems: Joint Dislocation

  MAUDE report 6949044 ↗