S-ROM 56-3517Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 10603295178200), received between Dec 17, 2014 and Feb 26, 2026 — classified as 127 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (19 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 129 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Fracture

  PATIENT WAS REVISED DUE TO THE SROM NECK SHEERED OFF OF STEM. ORIGINAL SURGERY DATE WAS (B)(6) 2018. DOI: 2018, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455734 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WAS REVISED DUE TO PSEUDOTUMOR FORM METAL BEARING SURFACE. REVISION NOTES REPORTED OF SEVERE EROSIVE CHANGES AND EXTENSIVE SOFT TISSUE MASS CONSISTENT WITH PSEUDOTUMOR. THE ANTERIOR CAPSULE WAS INCISED WITH RELEASE EXTENSIVE AMOUNT OF BROWN DISCOLORED FLUID. THERE WAS ALSO SIGNIFICANT TENDINOSIS VISIBLE AND BONE EROSION. CLINICAL VISITS REPORTED OF PAIN, WEAKNESS, OSTEOLYSIS, AND BONE LOSS.

  Patient problems: Arthritis; Bone Notching; Cyst(s); Fatigue; Osteolysis; Pain; Pocket Erosion; Swelling/ Edema

  MAUDE report 23582020 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTS REMOVED DUE TO INFECTED HIP, PLACED PROSTHETIC, STEM, AND ALL POLY LINER. DOI: UNKNOWN. DOR:(B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22358975 ↗
• InjuryJan 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT IMPLANT BROKE AT NECK JUNCTION. A NEW IMPLANT WAS NEEDED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21157013 ↗
• InjuryOct 15, 2024Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED STATES THAT; UPDATE RECEIVED FOR: DATE OF REVISION: (B)(6) 2024 TREATMENT/IMPACT: READMITTED ON (B)(6) 2024 FOR REVISION.

  Patient problems: Fall; Foreign Body Reaction; Pain

  MAUDE report 20451494 ↗
• InjuryDec 4, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF STEM. DOI: (B)(6) 2021 DOR: NOVEMBER 15, 2023 AFFECTED SIDE: RIGHT HIP

  Patient problems: Inadequate Osseointegration

  MAUDE report 18256628 ↗
• InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED DUE TO LEG LENGTH DISCREPANCY FROM A DYSPLASTIC HIP. SURGEON REMOVED STEM AND FEMORAL HEAD AND THEN REMOVED A 3CM SECTION OF THE FEMUR. CANAL WAS REAMED WITH FLEXIBLE REAMERS. HE THEN TRIALED A 11X16 36 STD +6 STEM AND A 36 +9 FEMORAL HEAD. THOSE SIZES WERE THEN IMPLANTED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 16033247 ↗
• InjuryOct 14, 2022Use of Device Problem; Use of Device Problem

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 15606406 ↗
• InjuryJul 12, 2022Fracture; Fracture

  PATIENT WAS REVISED AS THE STEM BROKE ABOVE THE SLEEVE. THERE WAS NO SURGICAL DELAY REPORTED. THERE WAS NO LOOSENING REPORTED. DOI: (B)(6) 2004; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 14985793 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2021. SALES REP WAS UNABLE TO PULL UP REVISION RECORDS. PATIENT HAS HAD SOME HIP INSTABILITY ISSUES. PATIENT HAS EHLOR DANLOS SYNDROME. PATIENT COMPLAINED THAT THE LEG FELT TOO LONG. THE SURGEON FELT THAT IT WAS NEEDED TO HAVE THE HIP LENGTH AND OFFSET REDUCED AND THE GREATER TROCH TRANSFERRED TO TIGHTEN THE SOFT TISSUE. TRIAL REDUCTION WAS PERFORMED AND FELT TO BE STABLE. NEW STEM AND FEMORAL HEAD WERE IMPLANTED. SLEEVE AND ACETABULAR COMPONENTS WERE MAINTAINED FROM PREVIOUS SURGERY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity; Physical Asymmetry

  MAUDE report 14980948 ↗
• InjuryJun 29, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION COMPLAINT RECEIVED AD (B)(6) 2022. PATIENT WAS REVISED WAS DUE TO HIGH HEAVY METAL POISONING. RECORDS ALSO ALLEGES PAIN, INJURY, TOXIC HEAVY COBALT AND CHROMIUM DEBRIS, METALLOSIS, METAL WEAR, EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6) 2012, DOR: (B)(6) 2021 UNK HIP.

  Patient problems: Discomfort; Distress; Fibrosis; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Physical Asymmetry; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 14855646 ↗
• InjuryDec 7, 2021Fracture; Fracture

  QUESTION: A. WAS THE PATIENT EXPERIENCING ANY ADVERSE SYMPTOMS THAT LED TO THE REVISION SURGERY? ANSWER: THE BROKEN STEM I¿M SURE CAUSED ISSUES BUT DON¿T KNOW EXACTLY WHAT THAT MIGHT BE! IT WAS NEVER STATED.

  Patient problems: Insufficient Information

  MAUDE report 12953026 ↗
• InjuryOct 4, 2021Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT BOTH STEM AND SLEEVE WERE LOOSE - UNDERSIZED. THE AFFECTED SIDE OF THE PATIENT WAS THE RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12573912 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR CUP WITH SROM STEM PRIMARY HIP DONE APPROX 15 YEARS AGO. PT PRESENTED WITH CARDIAC SYMPTOMS TO ED, INFECTION IN HIP NOTED. SAME REVISED TODAY. ALL IMPLANTS REMOVED, CEMENT SPACER INSERTED. DOI: 2006. DOR: (B)(6) 2021. UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 12554186 ↗
• InjurySep 29, 2021Degraded; Degraded

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORD, IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR FAILED LEFT THA WITH RECALLED METAL ON METAL ON METAL DESIGN WITH MASSIVE PELVIC ASSOCIATED BONE LOOSE AND PSEUDOTUMOR. OPERATIVE NOTES REPORTED THAT THERE WAS A CHRONIC NON-UNION OF GREATER TROCHANTERIC FRACTURE. THERE WAS A DENSE DARK GRAY ORGANIZED MASS PROTRUDING FROM THE POSTERIOR PSEUDO CAPSULE. THERE WERE AREAS WITHIN THE MASS OF FRANK NECROSIS. DEBRIDED INTRACAPSULAR TISSUE THAT WAS SIMILARLY CONSISTENT WITH PSEUDOTUMOR. THERE WAS GROSS EVIDENCE OF TAPER JUNCTION CORROSION WITH BLACK DEBRIS ALONG THE TRUNNION. THERE WAS EXTENSIVE BLACK NECROTIC PASTRY DEBRIS BEHIND THE CUP. THE ANTERIOR COLUMN WAS LARGELY ABSENT DOWN INTO A SIGNIFICANT PORTION OF THE PUBIC ROOT. THERE WAS ESSENTIALLY NO ANTERIOR WALL. THERE WAS A SIGNIFICANT CAVITY EXTENDING UP THE ILIUM SIMILARLY FILLED WITH BLACK PASTY DEBRIS THAT WAS DEBRIDED. DOI: (B)(6) 2009, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; Nonunion/Delayed-union Bone Fracture; Unspecified Tissue Injury

  MAUDE report 12547657 ↗
• InjurySep 23, 2021Degraded; Migration; Degraded; Migration

  (B)(4). LITIGATION PAPERS ALLEGE PAIN AND DISCOMFORT IN HER LEFT HIP CAUSING POTENTIAL UNNECESSARY AND ADDITIONAL SURGERIES, DIMINUTION IN EARNING CAPACITY, LOST WAGES, MEDICAL MONITORING EXPENSES, EMOTIONAL DISTRESS, LOSS OF ENJOYMENT OF LIFE, METALLOSIS EXPOSURE AND OTHER INJURIES PRESENTLY UNDIAGNOSED. FURTHER ALLEGED THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP) PATIENT IS RESIDENT OF OR UPDATE: 12/6/2011 PLAINTIFF'S PRELIMINARY DISCLOSURE (PPD) FORM RECEIVED (B)(6) 2011. THERE WAS NO NEW INFORMATION RECEIVED THAT WOULD IMPACT THE OUTCOME OF THE INVESTIGATION. UPDATE AD 19 JUN 2019: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE ASR PLAINTIFF DISCLOSURE FORM RECORDS RECEIVED. PDF INDICATED THAT THE PATIENT HAD UNDERWENT REVISION SURGERY. REPORTED REVISION DATE. DOI: (B)(6) 2008. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Limb Fracture; Loss of Range of Motion; Muscular Rigidity; Pain; Physical Asymmetry

  MAUDE report 12518573 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND IMPLANT RECORD RECEIVED. PATIENT HAD AN INFECTION AND DISLOCATION AFTER 1ST REVISION. DOI: (B)(6) 2011. DOR: (B)(6) 2017, (LEFT HIP).

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

  MAUDE report 12495768 ↗
• InjuryJul 8, 2021Fracture; Fracture

  PATIENT PRESENTED WITH A SROM HIP THAT WAS DONE ABOUT 10 YEARS AGO. ONE OF THE DISTAL TIPS HAD FRACTURED FROM THE STEM. SURGEON REMOVED STEM AND SLEEVE AND CHANGED THE INSERT. ALL PARTS WERE RETRIEVED FROM THE PATIENT. DOI: (B)(6) 2011 - (B)(6) 2021 (RIGHT HIP)

  Patient problems: Insufficient Information

  MAUDE report 12135655 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE UNKNOWN. PATIENT SUFFERED A HIP DISLOCATION OF SROM HIP AND CONSTRAINED LINER. SURGEON WAS NOT AWARE OF THE PATIENTS PREVIOUS SURGICAL DATES OR REASONS FOR SURGERY. SURGEON FELT THIS PATIENT WAS DEALING WITH SOME HIP IMPINGEMENT OF THEIR +4/10 DEGREE CONSTRAINED LINER ON THE NECK OF THE SROM STEM. HE FELT THEY WOULD BENEFIT FROM CONVERTING THE LINER TO JUST A +4 NEUTRAL CONSTRAINED LINER. HE ALSO FELT THE PATIENT WOULD BENEFIT FROM REPLACING THE STEM SO HE COULD ADJUST THE VERSION A BIT. A TRIAL REDUCTION WAS PERFORMED WITH THE NEW STEM AND A +4 NEUTRAL CONSTRAINED LINER AND A 28MM +3 HEAD WAS FOUND TO BE SATISFACTORY. THE REAL LINER AND HEAD WERE OPENED AND IMPLANTED. THE HIP WAS REDUCED AND FOUND TO BE STABLE. THE CLOSING PROCESS BEGAN. DOI: UNKNOWN; DOR: (B)(6) 2021 (RIGHT HIP).

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

  MAUDE report 12003216 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD RISING METAL ION LEVELS AND IT WAS SUGGESTED THAT SHE HAVE HER ASR CUP REMOVED AND REPLACE WITH A STANDARD CUP AND POLY LINER. RIGHT HIP. THE ASR CUP WAS REMOVED AND A COMPETITOR MDM SYSTEM WAS REPLACED. SURGEON STATED THAT THE HIP LOOKED PRISTINE WHEN HE WENT IN AND WAS ABLE TO EASILY REMOVE THE CUP AND ASR HEAD AND REPLACED WITH THE COMPETITOR MDM SYSTEM. HE PLACED AN SROM +0 CERAMIC 28MM HEAD. DOI: UNK, DOR: (B)(6) 2021, RIGHT HIP.

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

  MAUDE report 11957955 ↗
• InjuryApr 15, 2021Fracture; Fracture

  HIP REVISION TO REMOVE BROKEN SROM AND PATIENT REPORT OF PAIN.

  Patient problems: Pain

  MAUDE report 11670674 ↗
• InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO HIP AND LEG PAIN. STEM AND HEAD REMOVED AND REVISED WITH COMPETITORS COMPONENT. COMPETITOR CUP WAS NOT REVISED. NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 11378150 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS DISLOCATION AND METALLOSIS. ON (B)(6) 2007, THE PATIENT HAD A RIGHT PRESS-FIT TOTAL HIP ARTHROPLASTY TO ADDRESS END-STAGE OSTEOARTHRITIS. DEPUY COMPONENTS WERE UTILIZED, INCLUDING S-ROM STEM. THE CUP WAS NOTED TO HAVE BEEN PLACED IN ABOUT 40-45 DEGREES OPEN ABDUCTION AND ABOUT 25 DEGREES ANTEVERSION THAT MATCHED HER VERSION ANATOMICALLY. THERE WERE NO COMPLICATIONS NOTED DURING THE SURGERY. ON (B)(6) 2021, THE PATIENT HAD A REVISION RIGHT TOTAL HIP ARTHROPLASTY WITH ACETABULAR CUP/LINER AND FEMORAL HEAD, TO ADDRESS FAILED RIGHT HIP, RECURRENT INSTABILITY, METALLOSIS WITH MILD ADVERSE REACTION TO METAL DEBRIS. THE PATIENT HAS HAD MULTIPLE DISLOCATION WHICH INCLUDED PAIN AND SWELLING PRIOR TO SURGERY. THE SURGEON INCLUDED IN HIS FINDINGS: MILD ADVERSE REACTION TO METAL DEBRIS, MOST LIKELY IMPINGEMENT OF THE NECK ON THE METAL LINER, MILD TRUNNIONOSIS ¿LITTLE BIT OF LYSIS AND/OR JUST STRESS SHIELDING IN THE BONE IN THE ACETABULUM, AND A PSEUDOTUMOR. THE ACETABULAR CUP WAS NOTED TO BE ¿SLIGHTLY MALPOSITIONED, SLIGHTLY VERTICAL, SLIGHTLY OVER-ANTEVERTED¿. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PRO

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11287877 ↗
• InjuryFeb 5, 2021Fracture; Fracture

  PATIENT PRESENTED TO EMERGENCY DEPARTMENT. FRACTURED SROM STEM JUST BELOW THE TOP OF THE SLEEVE - IMPLANTED 10 YEARS AGO AT (B)(6) HOSPITAL. THE REVISION SURGERY HAS BEEN CONFIRMED AS HAVING TAKEN PLACE ON (B)(6) 2021. THE PATIENT ((B)(6) YO) HAD TO HAVE THE STEM AND THE SLEEVE REMOVED AS THE SURGEON COULDN'T MANAGE TO REMOVE THE DISTAL STEM ON IT¿S OWN. ENOUGH BONE REMAINED TO USE AN SROM STEM FOR THE REVISION WITHOUT HAVING TO USE A DISTALLY FIXING STEM.

  Patient problems: Insufficient Information

  MAUDE report 11285663 ↗
• InjuryJan 4, 2021Migration; Migration

  IT WAS REPORTED THAT THE STEM ON RIGHT SIDE BECAME INFECTED AND SUBSIDED SUBSTANTIALLY AND LOOSENING OF THE UNKNOWN COMPONENT AT BONE TO IMPLANT INTERFACE. WE REMOVED FEMORAL AND ACETABULAR CONSTRUCTS AND REPLACED WITH PROSTALAC. DOI: (B)(6) 2018 DOR: (B)(6) 2020 RIGHT HIP.

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

  MAUDE report 11108289 ↗