S-ROM 56-3618Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 10603295178224), received between Aug 12, 2015 and Feb 4, 2026 — classified as 118 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (11 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 121 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE-RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24261994 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2015. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 24165152 ↗
• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT ORIGINALLY HAD A HIP REPLACED IN NOVEMBER 2024. THE PATIENT DEVELOPMENT AN INFECTION IN THE RIGHT HIP. ALL THE COMPONENTS WERE EXPLANTED AND REPLACED WITH A PROSTALAC STEM.

  Patient problems: Unspecified Infection

  MAUDE report 22084815 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION OF HEAD, LINER, AND STEM WAS DONE FOR STABILITY ISSUES (RELATED TO POLYETHYLENE WEAR). NEEDED TO CHANGE THE STEM VERSION TO MAKE PATIENT MORE STABLE AND TO STOP IMPINGEMENT. IT WAS MENTIONED THAT THE CUP COULD HAVE BEEN MALPOSITIONED. PROCEDURE WAS NOT EXTENDED DUE TO THIS EVENT. THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21962445 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING AND THE TRUNION OF THE SROM NECK WAS IMPINGING ON THE CUP. THE STEM AND HEAD WERE EXTRACTED. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 21513551 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED: THE PATIENT SUFFERED PERSONAL AND ECONOMIC INJURIES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT. SEVERE AND DEBILITATING PAIN AND WEAKNESS; SIGNIFICANT INHIBITIONS OF HIS ABILITY TO WALK OR MOVE; METALLOSIS, ELEVATED BLOOD LEVELS OF CHROMIUM AND COBALT; ANXIETY, FEAR, MENTAL ANGUISH AND OTHER EMOTIONAL AND PHYSICAL DAMAGES. AFFECTED SITE: RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Distress; Emotional Changes; Fatigue; Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 21136866 ↗
• InjuryJun 27, 2024Degraded; Osseointegration Problem; Migration; Degraded; Osseointegration Problem; Migration

  PATIENT HAD A FAILED ACETABULAR COMPONENT ON METAL-ON-METAL TOTAL HIP WITH EVIDENCE OF TRUNNION CORROSION AND NO EVIDENCE OF INFECTION. DURING THE OPERATION, THERE WAS NO EVIDENCE OF PUS AND METALLOSIS BUT THERE WAS SOME MILD STAINING METALLIC LOOKING IN THE INFERIOR ASPECT OF THE ACETABULUM. THERE WAS SOME MILD STAINING BEHIND THE LINER BUT VERY MINIMAL. THE STEM WAS GROSSLY LOOSE, HAD ROTATED INTO RETROVERSION AND WAS GROWN OVER WITH BONE. THE HEAD HAD SOME CORROSION OF THE TAPER. THE SLEEVE WAS THEN CUT USING SHARP DISSECTION BECAUSE IT WAS SCARRED DOWN. DOI: (B)(6) 2009. DOR: (B)(6) 2014. LEFT HIP.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 19623381 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO DOTS CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2024 , DATE OF EVENT: (B)(6) 2024 (RIGHT HIP). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Limb Fracture

  MAUDE report 19567637 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR ADVERSE REACTION TO METAL DEBRIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2010, DATE OF EVENT: 04 APR 2024, (RIGHT HIP). TREATMENT: NONE

  Patient problems: Foreign Body Reaction

  MAUDE report 19460854 ↗
• InjuryJan 2, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  ON (B)(6) 2023, THE PATIENT UNDERWENT A TOTAL LEFT HIP REVISION ARTHROPLASTY. INTRAOPERATIVE FINDINGS INCLUDED THAT THE SROM SLEEVE AND STEM WERE GROSSLY LOOSE AT THE BONE-TO-IMPLANT INTERFACE. OSTEOTOMES AND AN OSCILLATING SAW WERE CREATED TO CLEAR AWAY EXTRA BONE TO RELEASE THE STEM AND SLEEVE. SUBSIDENCE WAS ALSO IDENTIFIED WHICH ALSO CAUSED A LOSS OF LEG LENGTH. THE PATIENT WAS CONVERTED TO A DUAL MOBILITY SYSTEM BUT NO ALLEGATIONS WERE NOTED AGAINST THE ORIGINAL LINER/HEAD. USFDA DETERMINATION: THE PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM AND SLEEVE IN THE FEMORAL BONE. THE STEM/SLEEVE ARE BEING REPORTED AS THEY ARE WHAT WAS NOTED TO BE GROSSLY LOOSE. THE REVISION OF THE LOOSE STEM/SLEEVE LED TO SUBSIDENCE, WHICH THEN LED TO THE LEG LENGTH DISCREPANCY, WHICH CAUSED THE SURGEON TO CONVERT TO A DUAL MOBILITY SYSTEM THE EVENT DESCRIPTION NOTED "NO ALLEGATIONS WERE NOTED AGAINST THE ORIGINAL LINER/HEAD.". THERE WAS ALSO NOT ALLEGATIONS OF DEFICIENCY NOTED FOR THE CUP AND SCREWS. DOI: (B)(6) 2016. DOR: (B)(6) 2023. LEFT HIP. PLEASE SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Inadequate Osseointegration; Physical Asymmetry

  MAUDE report 18426454 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND BROKE THE LEFT FEMUR. FEMORAL STEM, SLEEVE AND HEAD WERE REMOVED TO FIX FRACTURE. NEW STEM, SLEEVE AND HEAD WERE REPLACED. NO ADDITIONAL INFO AVAILABLE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 18074600 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 16553853 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. DOI- (B)(6) 2023. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16537304 ↗
• MalfunctionFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS AFTER CLINIC VISIT XRAY SHOWS SROM IMPLANT WITH PROBABLE LOOSENING REPORTED AFTER FIRST REVISION. CLINIC VISITS REPORTED OF PAIN, DIFFICULTY OF WALKING AND REQUIRED TO USE OF A CRUCTH TO WALK. THERE IS A STABLE SMALL AMOUNT OF LUCENCY ADJACENT TO THE FEMORAL COMPONENT. X-RAYS SHOW S-ROM PROSTHESIS WITH LUCENCY AROUND PROXIMAL SLEEVE. DATE OF EVENT: (B)(6) 2019. PLEASE SEE (B)(4) FOR 1ST REVISION.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 16416168 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED EXCEPT THE PROXIMAL SLEEVE. NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AND AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16405836 ↗
• InjuryFeb 14, 2023Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2006, DATE OF REVISION: (B)(6) 2022, (RIGHT HIP). TREATMENT: REVISION; HEAD, LINER AND SHELL WERE REVISED.

  Patient problems: Cyst(s); Foreign Body Reaction; Low Blood Pressure/ Hypotension; Necrosis; Sepsis; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16371660 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SMALL CALCAR FX INTRAOPERATIVE; PERIPROSTHETIC FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT HIP). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Limb Fracture

  MAUDE report 15979097 ↗
• InjuryDec 6, 2022Osseointegration Problem; Osseointegration Problem

  CORAIL PINNACLE WITH CERAMIC BEARINGS REVISED DUE TO UNKNOWN REASON OF OSTEOLYSIS. SOME MARKING WAS SEEN ON THE CUP AND HEAD, AND SOME BONE LOSS OBSERVED IN THE ACETABULUM AND FEMUR. REVISED TO AN S-ROM WITH G7 DUAL MOBILITY CUP, SURGEON WAS AWARE THAT THIS IS OFF LICENSE USAGE. NO PRODUCTS CODES ARE AVAILABLE FOR EXPLANTED IMPLANTS AS NO RECORDS. SURGEON DEEMED THAT THE CUP LOOKED STABLE, BUT THE STEM EXHIBITED SIGNS OF LOOSENING. RADIOGRAPHICALLY THESE LOOKED TO HAVE BEEN IMPLANTED IN THE CORRECT ORIENTATION. NO IMPLANTS ARE AVAILABLE AS THESE HAVE BEEN SENT TO ROYAL PERTH RETRIVALS.

  Patient problems: Inadequate Osseointegration; Osteolysis; Unspecified Tissue Injury

  MAUDE report 15924039 ↗
• InjurySep 23, 2022Fracture; Fracture

  UNF AND PINNACLE NON MOM MEDICAL RECORDS RECEIVED. INITIAL REPORTED REASON FOR REVISION ARE THE FOLLOWING FRACTURED PROSTHETIC FEMORAL STEM, PAIN, DISCOMFORT, CLICKING SENSATION, HETEROTOPIC BONE OSSIFICATION, IMPINGEMENT, METALLOSIS, AWAITING FOR MEDICAL RECORDS REVIEW TASK FINDINGS. ONCE AVAILABLE THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. DOI: (B)(6) 2010; DOR: (B)(6) 2014 ; LEFT HIP.

  Patient problems: Discomfort; Extraskeletal ossification; Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 15469485 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION RECORD RECEIVED. LITIGATION ALLEGES ELEVATED METAL IONS RESULTING TO HIP PAIN. DOI: (B)(6) 2007. DOR: (B)(6) 2021. AFFECTED AREA: LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Necrosis; Pain; Swelling/ Edema

  MAUDE report 14242842 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016, DATE OF EVENT: (B)(6) 2022, (RIGHT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Ambulation or Postural Difficulties; Fall; Joint Laxity; Pain

  MAUDE report 13505570 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ADVERSE LOCAL TISSUE REACTION - HIGH COBALT BLOOD LEVELS. EVENT IS NOT SERIOUS AND IS CONSIDERED. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2005; DATE OF EVENT (ONSET): (B)(6) 2021 (LEFT HIP). TREATMENT: REVISION OF THE HEAD AND LINER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Scar Tissue; Swelling/ Edema

  MAUDE report 13422764 ↗
• InjuryJan 27, 2022Fracture; Fracture

  THE STEM WAS BROKEN AT MOST PROXIMAL JUNCTION. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 13367617 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT THA COMPLETED DUE TO OSTEOARTHRITIS. A DEPUY ASR HEAD, ASR CUP, AND TAPER SLEEVE ADAPTER WERE USED. PATIENT COMPLETED OF AUDIBLE NOISE AND POPPING IN THE HIP. REVISION COMPLETED SECONDARY TO ADVERSE METAL-ON-METAL REACTIONS AND COBALT CHROMIUM TOXICITY. PATIENT HAD MODERATE ALVAL LIMITED TO THE CAPSULE WITH SMALL AMOUNTS OF TISSUE NECROSIS AROUND THE CAPSULE. DOI: (B)(6) 2007; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Loss of Range of Motion; Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13190907 ↗
• InjuryNov 2, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW, THE PATIENT WAS REVISED DUE TO METALLOSIS OF THE RIGHT HIP. DURING THE PROCEDURE, THE SURGEON HAS TO TAKE DOWN THE GLUTEUS MAXIMUS TENDON BECAUSE OF THE SIGNIFICANT STIFFNESS IN THIS HIP. UPON ASSESSMENT OF THE TAPER, IT HAS MILD CORROSION SO IT HAS BEEN CLEANED OFF. ADDITIONALLY, THE ACETABULAR COMPONENT WAS SLIGHTLY UNDER ANTEVERTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Muscle/Tendon Damage; Muscular Rigidity; Osteolysis; Pain

  MAUDE report 12738588 ↗