S-ROM 52-3191Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295170853), received between Aug 16, 2017 and Aug 8, 2024 — classified as 21 injuries, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT BROKEN SROM STEM. SURGEON EXPLANTED STEM REVISING WITH RECLAIM MONOBLOCK. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19938010 ↗
• InjuryMay 15, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAD A REVISION OF LEFT HIP. THE STEM WAS LOOSE. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19323937 ↗
• InjuryFeb 8, 2023Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  PATIENT HAS A TOTAL HIP REPLACEMENT DONE IN 2008 WHICH REQUIRES REVISION AS THE STEM BROKE AND IS ALSO LOOSE. DOI: 2008. DOR: (B)(4) 2023. UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 16322045 ↗
• InjuryAug 26, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE SROM STEM BROKEN AS SEEN IN PREOP XRAY.

  Patient problems: Insufficient Information

  MAUDE report 12373108 ↗
• InjuryAug 3, 2021Fracture; Fracture

  FRACTURED S-ROM STEM 14X09X130 WITH 14D SLEEVE. LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 12270355 ↗
• InjuryDec 21, 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, THE PATIENT WAS REVISED DUE TO METAL-ON-METAL LEFT TOTAL HIP REPLACEMENT WITH ION PRODUCTION SECONDARY PAIN. OPERATIVE NOTES REPORTED THAT THE LINER AND HEAD WERE SLIGHTLY DISCOLORED. DOI: (B)(6) 2004. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11047954 ↗
• InjuryOct 29, 2020Naturally Worn; Naturally Worn

  REVISION TOTAL HIP REPLACEMENT; DR (B)(6), (B)(6) HOSPITAL, (B)(6) 2020: REVISION DUE TO DISLOCATION AND INSTABILITY. CASE WILL LIKELY HAVE PREVIOUS REPORTS AS PREVIOUS REVISION ((B)(4)) HAS OCCURRED FOR INSTABILITY NECK OF SROM STEM NOTCHED DUE TO IMPINGEMENT WITH ACETABULAR COMPONENT. EVIDENCE OF MACROSCOPIC STAINING FROM METAL WEAR IMPINGEMENT OF FEMORAL STEM WITH ACETABULAR COMPONENT.

  Patient problems: Joint Disorder; No Code Available

  MAUDE report 10754582 ↗
• InjuryJan 30, 2020Fracture; Fracture

  THE PATIENT WAS REVISED TO ADDRESS BROKEN STEM. DOI: (B)(6) 2014; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9649141 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 07 JAN 2020 WERE REVIEWED ON 09 JAN 2020 BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. PRIMARY OPERATIVE NOTES (B)(6) 2012 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REPLACEMENT WITH 1-STAGE FEMORAL SHORTENING DUE TO CROWE IV CONGENITALLY DISLOCATED HIP. A FEMORAL BONE FRAGMENT WAS GENERATED AND THEN SECURED BY CERCLAGE WIRE FOR BONE GRAFTING. DOI: (B)(6) 2012; DOR: NO REVISION REPORTED (RIGHT HIP).

  Patient problems: Bone Fracture(s); No Code Available; Osteolysis

  MAUDE report 9624834 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGED ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, NO REVISION NOTES REPORTED. DOI: (B)(6) 2007; DOR: (B)(6) 2013 LEFT HIP. SEE (B)(4) RIGHT HIP.

  Patient problems: No Code Available; Test Result

  MAUDE report 8552228 ↗
• InjuryMar 27, 2019Biocompatibility; Biocompatibility

  PATIENT WAS REVISED TO ADDRESS PAIN. METALLOSIS WAS NOTED AT THE TIME OF THE REVISION. UPDATE 7/29/13 - LITIGATION PAPERS RECEIVED. RECEIPT OF PPF, AND MEDICAL RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS BEARING WEAR, RIGHT HIP, WITH METALLOSIS.

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

  MAUDE report 8455400 ↗
• InjuryMar 4, 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 AFTER FIRST REVISION. DOI: (B)(6) 2017 - DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 8387575 ↗
• InjuryDec 14, 2018Biocompatibility; Biocompatibility

  PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2005 - DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 8163949 ↗
• InjuryDec 12, 2018Loose or Intermittent Connection; Migration; Loose or Intermittent Connection; Migration

  THE PATIENT WAS REVISED DUE TO HIP PAIN. X-RAYS SHOWS SUBSIDENCE OF THE SLEEVE AND STEM. THE DOCTOR REVISED THE FEMORAL COMPONENT. CUP AND POLY AS WELL. STEM AND SLEEVE LOOSENING AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2013, DOR:NOV 16, 2018, RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8156080 ↗
• InjuryDec 11, 2018Biocompatibility; Biocompatibility

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM SEVERE PAIN, DISCOMFORT IN HER HIP, METALLOSIS, CONTINUED MEDICAL CARE INCLUDING REVISION, AND DIFFICULTY WALKING. UPDATE AD 12 JUN 2018: WPC (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. ADDED CUP AND SCREWS DUE TO ALLEGED LOOSENING AND STEM DUE TO ALLEGED ELEVATED METAL IONS.

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

  MAUDE report 8150487 ↗
• InjuryJul 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES STROKE, HEART ATTACK AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, FOR MDR REPORTABILITY, THERE IS NO REVISION REPORTED. DOI: (B)(6) 2016; DOR: NOT REPORTED; (RIGHT HIP).

  Patient problems: Cardiac Arrest; Infarction, Cerebral; Test Result

  MAUDE report 7713891 ↗
• InjuryJul 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES STROKE, HEART ATTACK AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, FOR MDR REPORTABILITY, THERE IS NO REVISION REPORTED. DOI: (B)(6) 2017- DOR: NOT REPORTED (LEFT HIP).

  Patient problems: Cardiac Arrest; Infarction, Cerebral; Test Result

  MAUDE report 7713709 ↗
• MalfunctionMay 29, 2018Fracture; Fracture

  TOTAL HIP JOINT REPLACEMENT - (B)(6); (B)(6) HOSPITAL (B)(6) 2018. SURGEON TOLD (B)(4) REPRESENTATIVE (B)(4) 2018 HE SAW A FOLLOW UP PATIENT RECENTLY WHO APPEARS TO HAVE A HAIRLINE FRACTURE ON THE STEM THAT IS INSITU. (B)(4) REPRESENTATIVE ADVISED SURGEON THAT REP WILL HAVE TO REPORT THIS, REP OBTAINED THE LOT NUMBERS OF THE STEM IN QUESTION. INITIAL PAIN THAT SETTLED. PATIENT IS NOW PAIN FREE AND ASYMTOMATIC, AND DOES NOT REQUIRE REVISION SURGERY AT THIS STAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7549535 ↗
• InjuryJan 31, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2015; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7230199 ↗
• InjuryDec 15, 2017Corroded; Appropriate Device Problem Term/Code Not Available; Corroded; Appropriate Device Problem Term/Code Not Available

  PATIENT REVISED TO ADDRESS INSTABILITY AND "HYDRAULIC EFFECT FROM JOINT EFFUSION" UPDATE NOV 21, 2017: LITIGATION RECORD RECEIVED. LITIGATION ALLEGES CORROSION AND FRICTION CAUSING TOXIC COBALT-CHROMIUM METAL DEBRIS, PAIN AND DISABILITY. ADDED STEM FOR THE ALLEGED CORROSION. ADDED NEW COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON NOV 22, 2017.

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Headache; Host-Tissue Reaction; Injury; Joint Disorder; Limited Mobility Of The Implanted Joint; No Code Available; Not Applicable; Pain; Tissue Damage

  MAUDE report 7123052 ↗
• InjuryNov 22, 2017Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE: (B)(6) 2017: PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED. PFS ALLEGES ACHES, SWELLING, CLICKING AND INABILITY TO WALK, PICK, BEND, LIFT AND CROSS LEGS FOR A LONG PERIOD OF TIME. IT WAS ADDED THAT THERE WAS LIMITATION AND INJURIES. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT TOTAL HIP ARTHROPLASTY WITH SIGNIFICANT INFLAMMATORY SYNOVITIS. REVISION NOTES REPORTED OF NO NEW ALLEGATION. THIS COMPLAINT WAS UPDATED ON (B)(6) 2017.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Limited Mobility Of The Implanted Joint; Pain; Tissue Damage

  MAUDE report 7053469 ↗
• InjuryAug 16, 2017Migration or Expulsion of Device; Loss of Osseointegration; Migration or Expulsion of Device; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF SROM STEM AND SLEEVE WITH SUBSIDENCE, BONE TO IMPLANT INTERFACE.

  Patient problems: No Information

  MAUDE report 6798535 ↗