S-ROM 52-3420Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10603295171041), received between Dec 4, 2014 and Jan 5, 2026 — classified as 2 deaths, 70 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM AND SLEEVE AT NON CEMENTED INTERFACE AND SUBSIDENCE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23961367 ↗
• InjuryMay 2, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SEPTIC STEM WAS LOOSEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. AFFECTED AREA: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21950375 ↗
• InjuryOct 7, 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 OTHER SURGICAL SITE IS THIS EVENT RELATED TO THE STUDY DEVICE? DEFINITELY IS THIS EVENT RELATED TO THE STUDY PROCEDURE? DEFINITELY NOT DEVICE LOCATION: LEFT DATE OF EVENT: ON (B)(6) 2024 DATE OF IMPLANT: NO INFORMATION PROVIDED TREATMENT/IMPACT: LEFT HIP REVISION PERFORMED (B)(6) 2024.

  Patient problems: Foreign Body Reaction

  MAUDE report 20382388 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. 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: (B)(6) 2000. DATE OF EVENT: (B)(6) 2024. (RIGHT HIP). TREATMENT: REVISION; LINER, STEM, AND HEAD WERE REVISED.

  Patient problems: Pain

  MAUDE report 18861066 ↗
• InjuryFeb 1, 2024Use of Device Problem; Use of Device Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, POPPING/SNAPPING, DIFFICULTY AMBULATING, AND ELEVATED METAL ION LEVELS. UPDATE: 7/3/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE PATIENT WAS REVISED ON THE LEFT SIDE BECAUSE OF METALLOSIS, VERTICAL CUP, AND SLIGHT CORROSION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 30 AUG 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS AND IMPLANT RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, METALLOSIS AND METAL WEAR. ADDED LAW FIRM, LAWYER, EXPIRY DATE OF THE HEAD, PATIENT HARM AND PEC. DOI: (B)(6) 2004 - DOR: NONE REPORTED (RIGHT HIP) PLEASE SEE (B)(4) FOR THE LEFT HIP.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Discomfort; Extraskeletal ossification; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 18623283 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6); STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2010, DATE OF REVISION: (B)(6) 2011, (LEFT HIP). TREATMENT: STEM, HEAD, CUP AND LINER WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 18483824 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND WORSENING FUNCTION, ELEVATED COBALT, AND CHROMIUM LEVELS. DOI: (B)(6) 2006. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP. THIS PC IS BILATERAL HIP ARTHROPLASTY LINKED TO PC-(B)(4) RIGHT HIP ARTHROPLASTY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17406165 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND WORSENING FUNCTION , ELEVATED COBALT AND CHROMIUM LEVELS. DOI: (B)(6), 2006. DOR: (B)(6), 2022. AFFECTED SIDE: RIGHT HIP. THIS PC IS BILATERAL HIP ARTHROPLASTY LINKED TO (B)(4), LEFT HIP ARTHROPLASTY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17397043 ↗
• InjuryMar 15, 2022Degraded; Degraded

  MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT TOTAL HIP, MOM REACTION. REVISION NOTES STATED THAT THERE WAS OBVIOUS DISTENTION OF POSTERIOR ROTATORS OR CAPSULE THAT WAS ASPIRATED AND FOUND TO BE MILKY COLORED. THERE WAS OBVIOUS METAL STAINING OF THE SYNOVIUM. THERE WAS CORROSION ON THE TAPER. MEDICAL RECORDS INDICATE THAT THE CORROSION ON THE TRUNNION OF THE FEMORAL STEM WAS CLEANED OFF. THE STEM AND SLEEVE WERE WELL-FIXED AND THEREFORE RETAINED. DOI: (B)(6) 2007 - DOR: (B)(6) 2012 (LEFT HIP).

  Patient problems: Foreign Body Reaction; Pain; Swelling/ Edema

  MAUDE report 13770532 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED SECONDARY TO PATIENT COMPLAINTS OF PAIN IN RIGHT HIP. METAL FEMORAL HEAD AND METAL LINER WERE REPLACED WITH A CERAMIC FEMORAL HEAD AND A POLYETHYLENE LINER. SROM STEM AND PINNACLE CUP WERE NOT REPLACED. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT HIP.

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

  MAUDE report 13107991 ↗
• InjuryJun 14, 2021Degraded; Degraded

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP TO ADDRESS ADVERSE LOCAL TISSUE REACTION (ALTR). DATE OF IMPLANTATION: (B)(6) 2006. DATE OF REVISION: (B)(6) 2021 (RIGHT HIP). MEDICAL RECORDS REVIEWED: ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT HIP REVISION TO ADDRESS DISLOCATION, SYNOVITIS, PAIN, METALLOSIS, OSTEOLYSIS, PSEUDOTUMOR, AND CORROSION OF THE STEM TRUNNION. THE SURGEON INDICATED AFTER REMOVAL OF THE HEAD FROM THE STEM THERE WAS CORROSION COMPATIBLE WITH METALLOSIS, THE CORROSION WAS CLEANED OFF THE TRUNNION. THERE WAS EXTENSIVE SUPERIOR ILIAC BONE LOSS. THE CENTRAL DOME SCREW WAS REMOVED FROM THE WELL-FIXED CUP. THERE IS NO INDICATION THE SCREW WAS REPLACED. REMOVAL OF THE METAL LINER DEMONSTRATED EXTREME BACKSIDE COBALT CHROME METALLOSIS. PSEUDOTUMOR INVADED THE ABDUCTOR MUSCULATURE AND THE SHORT EXTERNAL ROTATORS OF THE FEMUR, AND EXTENSIVE OSTEOLYSIS OF THE MEDIAL ANTERIOR AND POSTERIOR PROXIMAL POROUS SLEEVE OF THE S-ROM COMPONENT. HOWEVER, THERE WAS RIGID FIXATION DISTALLY AND LATERALLY AND THE STEM WAS SOLID IN THE FEMUR. THE FEMORAL HEAD AND ACETABULAR LINER WERE REVISED. THE CENTRAL DOME SCREW WAS REMOVED BUT NO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Pain; Synovitis

  MAUDE report 11996294 ↗
• InjuryApr 9, 2021Degraded; Degraded

  ASR MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED METALLOSIS. CORROSION WAS NOTED ON THE TRUNNION. THE CUP WAS REMOVED WITHOUT DIFFICULTY AND CAME OUT WITH MINIMAL BONE. SOME AREAS WHERE THE POROUS COATING HAD BEEN ERODED BY THE PRESENCE OF SOME RETAINED STAINLESS STEEL HARDWARE FROM INTERNAL FIXATION OF THE ACETABULUM. DOI: (B)(6) 2006, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 11640860 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT SURGEON PERFORMED THE ORIGINAL SURGERY ON (B)(6) 2012. THE PATIENT ENDED UP DEVELOPING A HIP INFECTION AND NEEDING AN ANTIBIOTIC SPACER. THE SURGEON REMOVED THE SROM STEM AND PINNACLE ACETABULAR COMPONENTS. THE PATIENT WAS THEN PREPPED FOR A SIZE 1 HI OFFSET (SIZE 3 PROSTALAC MOLD). ONCE THE PROSTALAC STEM AND CUP WERE IMPLANTED, A FINAL TRIAL REDUCTION WAS PERFORMED. A SIZE 32MM +5 WAS DEEMED APPROPRIATE AND IMPLANTED. PATIENT LEG LENGTH AND STABILITY WAS CHECKED, FOUND TO BE SATISFACTORY, AND THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2012 - DOR: (B)(6) 2021 (RIGHT HIP).

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

  MAUDE report 11158152 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR SUPPLEMENTAL INFO AND MEDICAL RECORDS WERE RECEIVED. AFTER A REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS RIGHT TOTAL HIP ARTHROPLASTY FAILURE SECONDARY TO LEG-LENGTHENING EXCESSIVELY AND CALCAR FRACTURE. OPERATIVE NOTE REPORTED THAT THE FEMORAL NECK WAS NOTED TO HAVE CRACKED DURING THE INSERTION OF THE NEW STEM. DOI: (B)(6) 2009. DOR: (B)(6) 2010. RIGHT HIP.

  Patient problems: Bone Fracture(s); Physical Asymmetry

  MAUDE report 11118834 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL HIP TO ADDRESS METALLOSIS OF THE FEMUR AND ACETABULUM. DATE OF IMPLANTATION: (B)(6) 2002; DATE OF REVISION: (B)(6) 2020; (LEFT HIP). TREATMENT: REVISION OF THE METAL HEAD AND METAL LINER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Osteolysis; Pain

  MAUDE report 10931674 ↗
• DeathNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEATH, SECONDARY TO POSSIBLE GASTROINTESTINAL BLEED EVENT SERIOUS AND IS CONSIDERED SEVERE/FATAL. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS REMOTE POSSIBILITY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF REVISION (NON-STUDY HIP): (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020 (DAY UNKNOWN). (RIGHT HIP). TREATMENT: NONE.

  Patient problems: Death; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10838339 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10819020 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INFECTION. ALL IMPLANTS REMOVED EXCEPT FOR THE PROXIMAL SLEEVE. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10677819 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SOFT TISSUE INFECTION WITH POSSIBLE DEEP INFECTION EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF EVENT (ONSET): (B)(6) 2020 (RIGHT HIP). TREATMENT: NONE (AWAITING SURGICAL I&D WITH POSSIBLE REVISION).

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10559982 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING ABOUT SOME DISTAL THIGH PAIN SO THE SURGEON REMOVED THE HEAD AND STEM AND REPLACED THEM WITH NEW COMPONENTS. DOI: (B)(6) 2018. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10528121 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS THIGH PAIN. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10301626 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BURSITIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT HIP). TREATMENT: NONE (AWAITING SURGICAL BURSECTOMY).

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10298718 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW ECM RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT (B)(4). NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON (B)(6) 2009. PATIENT EXPERIENCED PAIN, INHIBITION OF THE ABILITY TO WALK, UNNECESSARY AND ADDITIONAL SURGERY, AND OTHER INJURIES PRESENTLY UNDIAGNOSED. PATIENT HAS BEEN AND/OR WILL BE FORCED TO UNDERGO A REVISION SURGERY. DOI: (B)(6) 2009 - DOR: N/I. PATIENT IS A RESIDENT OF (B)(6). UPDATE 8/8/12 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED (PART/LOT) INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE 09/23/13 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED WITH MEDICAL DOCUMENTS, WHICH IDENTIFIED DOB, DOI, DOR, SIDE INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DOI: (B)(6) 2009 - DOR: (B)(6) 2012 (LEFT HIP). UPDATE AD 20 DEC 2019. (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PFS AND MEDICAL RE

  Patient problems: Discomfort; Edema; Fever; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Hypoesthesia; Inflammation; Limited Mobility Of The Implanted Joint; Necrosis; Osteolysis; Pain; Seroma; Test Result; Tissue Damage; Unspecified Infection; Wound Dehiscence

  MAUDE report 9924265 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT TOTAL HIP ARTHROPLASTY. DOI: (B)(6) 2006; DOR: (B)(6) 2007; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9891732 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS INSTABILITY. PATIENT HIP WAS LOOSE, SUBLUXED AND HAVE A SWOLLEN THIGH AND HEMATOMA. REVISION NOTES STATED THAT THE HEAD,LINER,CUP, AND STEM WERE REVISED. LEG WAS LONGER AT THE LEFT SIDE. DOI: (B)(6) 2009; DOR: (B)(6) 2009; (LEFT HIP).

  Patient problems: Hematoma; Joint Disorder; No Code Available; Swelling

  MAUDE report 9806696 ↗