S-ROM 52-2033Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295170839), received between May 9, 2018 and Nov 18, 2025 — classified as 25 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (15 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Adverse 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. THE REASON FOR THE REVISION WAS DISCOMFORT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Discomfort

  MAUDE report 23586270 ↗
• InjuryJun 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF HIP. SURGEON IMPLANTED A COMPETITOR CUP. SURGEON REMOVED LINER AND PLACED A COMPETITOR CONSTRAINED LINER WITH A SROM HEAD. DOI: (B)(6) 2003. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19569779 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR MINOR PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2000, DATE OF EVENT: 29 FEB 2024, (RIGHT HIP). TREATMENT: REVISION; LINER, STEM, AND HEAD WERE REVISED.

  Patient problems: Pain

  MAUDE report 18861104 ↗
• InjuryOct 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A REMOVAL SURGERY OF MARATHON LINER AND 32 +3 SROM HEAD FOR SYNOVITIS AND DISLOCATION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; Synovitis

  MAUDE report 18002364 ↗
• InjuryOct 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LEFT HIP REVISION WAS REVISED DUE TO RECURRING HIP DISLOCATION POSTERIORLY. DOI- APRIL 18, 2023. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17919712 ↗
• InjurySep 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO SROM ON A SMNP CUP REOCCURRING DISLOCATIONS. EXPLANTED SMNP CUP REVISION TO PINNACLE. SROM METAL 32+6 DEPUY PRODUCT WAS EXPLANTED. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17797584 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO OSTEOLYSIS. DATE OF IMPLANT: (B)(6) 2002. DATE OF REVISION: (B)(6) 2022. (RIGHT HIP). TREATMENT: REVISION OF THE HEAD AND LINER.

  Patient problems: Cyst(s); Discomfort; Hypersensitivity/Allergic reaction; Osteolysis

  MAUDE report 15638515 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT PAIN AFTER THE INITIAL SURGERY. THIS PC REPORTS ABOUT INFECTION AFTER THE REVISION SURGERY. IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. AFTER SURGERY, THE PATIENT FELT PAIN AND THE HEAD WAS REPLACED IN THE REVISION SURGERY ON (B)(6) 2022. AFTER THE REVISION SURGERY, INFECTION OCCURRED. THE SECOND REVISION SURGERY IS PLANNED ON (B)(6) 2022. IN THE SECOND REVISION SURGERY, THE HEAD WILL BE REPLACED, OR CEMENT BEADS WILL BE USED FOR A TREATMENT.

  Patient problems: Unspecified Infection

  MAUDE report 14345401 ↗
• InjuryDec 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13078017 ↗
• InjuryOct 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. HEAD AND LINER EXCHANGE. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12664712 ↗
• InjuryMar 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS A CHRONIC DISLOCATOR. REMOVED FEMORAL HEAD AND LINER AND CONVERTED TO A CONSTRAINED INSERT. ORIGINAL IMPLANT. DATE UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11506781 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT THA PERFORMED OVER 20 YEARS AGO WITH NO INFORMATION AVAILABLE ABOUT THAT SURGERY. ON (B)(6) 2020. THE PATIENT HAD A RIGHT THA REVISION OF THE HEAD AND LINER FOR POLY WEAR REPORTED IN (B)(4). THE PATIENT RECEIVED A REREVISION TO TREAT PAIN SECONDARY TO TOO MUCH OFFSET AND LEG LENGTH. THIS NEW SURGEON WANTED TO REMOVED THE ENTIRE SROM CUP AND PUT IN A COMPETITOR DUAL MOBILITY AND NEEDED TO USE MY SROM 11/13 TAPER HEADS. THE SURGEON REMOVED THE METAL HEAD, POLY DIAL LINER AND LOCKING PINS, SCREW AND CUP. HE IMPLANTED A COMPETITOR DUAL MOBILITY HEAD AND USED MY 28MM +3 METAL SROM HEAD. HE WAS HAPPY WITH THE LEG LENGTHS AND OFFSET. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10752717 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ELEVATED METAL IONS. REMOVED 48X28 PINNACLE MOM LINER AND 28 PLUS 6 SROM HEAD. DOI: (B)(6) 2009; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available; Test Result

  MAUDE report 10721049 ↗
• InjuryOct 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS REVISED FOR INSTABILITY UNRELATED TO COMPONENT POSITION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10639432 ↗
• InjuryDec 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9401636 ↗
• InjuryOct 8, 2019Naturally Worn; Naturally Worn

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES PATIENT SUFFERS FROM PAIN, DISCOMFORT, INSTABILITY, AND ELEVATED LEVELS OF COBALT / CHROMIUM. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED CORROSION, IMPINGEMENT, METAL DEBRIS, AND LOOSE CUP. LAB RESULTS INDICTED THE METAL ION LEVELS WERE ABOVE 7PPB. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2013. DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Discomfort; Joint Disorder; Pain; Test Result

  MAUDE report 9168492 ↗
• InjurySep 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE SURGEON WAS REVISING THE CUP AND LINER DUE TO IMPROPER POSITIONING, CAUSING DISLOCATION. THE STEM AND FEMORAL HEAD WERE S-ROM IMPLANTS, BUT THE ACETABULAR COMPONENT AND LINER WERE STRYKER. IN ORDER TO GET A BETTER VIEW OF THE ACETABULUM, THE SURGEON OPTED TO REMOVE THE STEM AND FEMORAL HEAD. ONCE A NEW COMPONENT WAS IMPLANTED, THE SURGEON TRIALED A 20 X 15 36 +8 WITH A 40 MM +9 HEAD. HE NEEDED ADDITIONAL OFFSET AND LENGTH, SO HE DECIDED TO IMPLANT A 20 X 15 36 +12 SROM STEM WITH A 40 MM +12 11/13 FEMORAL HEAD. THE HIP WAS REDUCED AND THE CLOSING PROCESS BEGAN. DOI: 1995. DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9124998 ↗
• InjuryApr 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES ABDUCTOR MUSCLE REPAIR, DISLOCATION AND ELEVATED METAL IONS AFTER FIRST REVISION. ( RIGHT HIP).

  Patient problems: Joint Dislocation; Test Result; Tissue Damage

  MAUDE report 8529083 ↗
• InjuryApr 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8514583 ↗
• InjuryApr 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO INFECTION AND A BROKEN RING ON THE CONSTRAINED LINER. PPF ALLEGES CONSTRAINED LINER, AND DISLOCATION WITH OPEN AND CLOSED REDUCTION. DOR: (B)(6) 2009 - DOR: (B)(6) 2009 (RIGHT HIP).

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 8503287 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO POLYWEAR. DOI: (B)(6) 1999; DOR: (B)(6) 2019; (LEFT HIP). PLEASE NOTE, HEAD AND LINER WERE REVISED, ONLY THE HEAD WILL BE CAPTURED ON THE PC AS THE LINER IS COMPETITOR PRODUCT.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8459001 ↗
• InjuryNov 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION ALLEGES DISLOCATION AND BONE FRACTURE AFTER FIRST REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 8055330 ↗
• InjuryOct 23, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 7996161 ↗
• InjuryAug 23, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ACCORDING TO THE DOCTOR, PATIENT HAD A PSEUDO TUMOR ISSUE FROM WEAR BETWEEN HEAD AND STEM. PATIENT HAS BEEN PREVIOUSLY REVISED BY OTHER SURGEONS FOR SIMILAR ISSUES. DID A POLY HEAD SWAP. CUP AND STEM WERE FINE. NO OTHER ISSUES TO REPORT. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable; Tissue Damage

  MAUDE report 7808356 ↗
• InjuryMay 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LITIGATION PAPERS ALLEGE SINCE SURGICAL IMPLANTATION, PATIENT HAS SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, SORENESS AND DIFFICULTY WALKING. DOI: (B)(6) 2009 - DOR: NO REVISION REPORTED AT THIS TIME. (RIGHT SIDE) PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. ALTHOUGH LITIGATION REPORTED THIS AS METAL ON METAL, PRODUCT INFORMATION INDICATES THE PATIENT HAD POLY ON METAL. AS THE LITIGATION HAS ALREADY BEEN REPORTED, AND THERE IS NO REPORTED SERIOUS INJURY OR MALFUNCTION (PATIENT HAS NOT BEEN REVISED), THE REPORTING REQUIREMENTS HAVE BEEN MET. EVEN THOUGH PART/LOT INFORMATION WAS PROVIDED IT IS UNCLEAR WHAT PRODUCTS ARE AT ISSUE AS THE PATIENT HAS NOT BEEN REVISED THEREFORE THE PRODUCT PAGE WILL BE LEFT AS UNKNOWN UNTIL FURTHER INFORMATION IS RECEIVED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. PPF AND IMPLANT STICKER SHEET RECEIVED. THERE IS NO NEW ALLEGATION TO BE REPORTED. DOI: (B)(6) 2009 ; DOR: NOT REPORTED; RIGHT HIP; PINNACLE.

  Patient problems: Discomfort; Pain

  MAUDE report 7498257 ↗