S-ROM 52-3418Recalls & reported problems

Summary

The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 10603295171034), received between Nov 19, 2014 and Nov 14, 2025 — classified as 168 injuries.

The most frequently reported specific device problem is “Biocompatibility” (20 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 168 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 23561572 ↗
• InjuryAug 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT NEEDED MORE VERSION WITH A NEW STEM. DOI: (B)(6) 2021, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 22846244 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22751631 ↗
• InjuryJun 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE EXPLANTED EXCEPT FOR THE SROM SLEEVE DUE TO MALPOSITIONING. DOI: (B)(6) 2018. DOR: (B)(6) 2018. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22205064 ↗
• InjuryJan 9, 2025Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT THE DOCTOR DID A SROM PINNACLE TOTAL HIP ON THIS PATIENT ON AN UNKNOWN DATE IN 2011. THIS PATIENT DID FINE UNTIL RECENTLY WHEN PATIENT BEGAN TO EXPERIENCE PAIN. X-RAYS REVEALED THE SROM STEM HAD BROKEN DISTAL AT THE SLOT. ONE OF THE 2 SPLINES WAS FRACTURED OFF OF THE IMPLANT. DOCTOR REVISED THE HIP AND EXPLANTED THE SROM SLEEVE, SROM HIP BALL, SROM STEM, AND PINNACLE LINER. THE HIP BALL, STEM, SLEEVE, AND LINER WERE EXPLANTED WITHOUT TOO MUCH TROUBLE BUT IT DID TAKE APPROXIMATELY 45 MINUTES TO RETRIEVE THE BROKEN DISTAL SPLINE FROM THE SWIM STEM. A RECLAIM MODULAR STEM WAS THEN IMPLANTED WITH A PIN A LE DUAL MOBILITY CONSTRUCT. THE PATIENT IS A LARGE, ACTIVE PATIENT. X-RAYS INDICATE THE STEM BEGAN TO TILT INTO A VARUS POSITION WHICH CAUSED THE DISTAL TIP TO IMPINGE ON THE CORTEX OF THE FEMUR. OVER TIME THE DISTAL TIP OF THE IMPLANT BECAME FATIGUED AND FRACTURED. ALL PIECES WERE REMOVED FROM THE FEMUR; SURGICAL DELAY WOULD HAVE BEEN APPROXIMATELY 45MINUTES TO RETRIEVE BROKEN SROM STEM PIECE FROM CANAL. DOI: 2011, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 21118128 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. IT WAS REPORTED THAT THE STUDY PATIENT UNDERWENT SURGERY FOR THE LEFT KNEE. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE. DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. DATE OF EVENT: AUGUST 20, 2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 20438315 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: PROBABLY DATE OF EVENT: AUGUST 20, 2024 DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: NO INFORMATION PROVIDED

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Pulmonary Embolism; Renal Impairment; Respiratory Failure; Thrombosis/Thrombus

  MAUDE report 20326536 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE CUP, LINER AND STEM WERE ALL REMOVED AND REPLACED WITH PROSTALAC SPACER. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20258217 ↗
• InjuryJun 17, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO SEVERE HO AND BECAUSE THE S ROM STEM HAD MIGRATED INTO VARUS ALIGNMENT. THE SURGEON PERIOD AN ETO TO REMOVE THE S ROM STEM, S ROM SLEEVE AND FEMORAL HEAD. HE PREPPED AND PLACED A COMPETITOR STEM FOR THE FEMUR. HE REMOVED THE 62MM X 36MM NEUTRAL PINNACLE LINER AND REPLACED IT WITH A 62MM X 40MM NEUTRAL PINNACLE LINER. CASE WAS COMPLETED WITHOUT ISSUES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Extraskeletal ossification

  MAUDE report 19554395 ↗
• InjuryApr 19, 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 PERIPROSTHETIC FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. 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 19142445 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR CARDIOVASCULAR COMPLICATIONS (E.G. MI). EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2005. DATE OF EVENT: 14 MAR 2024. (LEFT HIP). TREATMENT: NONE.

  Patient problems: Myocardial Infarction

  MAUDE report 19019583 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: -THERE WAS A SURGICAL DELAY IN THAT THE CASE HAD TO BE PREFORMED IN ORDER TO REMOVE THESE ITEMS AND REIMPLANT. -THE ADVERSE CONSEQUENCES TO THE PATIENT IS THAT THEY HAD TO UNDERGO REVISION SURGERY IN LESS THAN 2 YEARS AFTER THE INITIAL SURGERY.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 18984285 ↗
• InjuryFeb 2, 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 CLOSED PERIPROSTHETIC FRACTURE - FEMORAL. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE OR PROCEDURE. DATE OF IMPLANT: (B)(6) 2019, DATE OF EVENT: (B)(6) 2024, (RIGHT HIP). TREATMENT: NONE.

  Patient problems: Limb Fracture

  MAUDE report 18634450 ↗
• InjuryAug 30, 2023Migration; Migration

  IT WAS REPORTED THAT SROM STEM WAS TAKEN OUT, THE CUP LINER WAS REPLACED WITH SAME SIZE THAT WAS PUT IN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 17650654 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP INFECTION. THE IMPLANTS WERE EXPLANTED AND AN ANTIBIOTIC PROSTALAC SPACER WAS IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2008 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17511374 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17405518 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 17061697 ↗
• InjuryJun 5, 2023Degraded; Degraded

  ON (B)(6) 2007, PATIENT RECEIVED A RIGHT TOTAL HIP REPLACEMENT USING S-ROM STEM AND PINNACLE CUP WITH METAL-ON-METAL ARTICULATION, TO ADDRESS END STAGE OSTEOARTHRITIS. THERE WAS NO REPORTED SURGICAL COMPLICATION. ON (B)(6) 2013, PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS ACUTE INFECTION. IRRIGATION AND DEBRIDEMENT WAS PERFORMED, WITH EXCHANGE OF ACETABULAR LINER AND FEMORAL HEAD. THERE WAS NO EVIDENCE OF METALLOSIS IDENTIFIED. THERE WAS EVIDENCE OF CORROSION ON THE STEM TRUNNION. THE CUP, HOLE ELIMINATOR, AND S-ROM STEM WITH SLEEVE WERE RETAINED. THERE WAS NO EVIDENCE OF OSTEOMYELITIS. ON (B)(6) 2023, PATIENT RECEIVED AN MRI OF THE RIGHT HIP. NO FINDINGS TO SUGGEST LOOSENING OF THE COMPONENTS OF THE RIGHT HIP IMPLANTS. OBSERVED 2 CM X 6 CM COMPLEX FLUID SIGNAL INTENSITY COLLECTION ALONG THE POSTERIOR MARGIN OF THE HIP JOINT AND PROXIMAL FEMUR. THIS COLLECTION COMMUNICATES WITH A DEFECT IN THE POSTERIOR PSEUDO CAPSULE AS WELL AS ABUTTING A CORTICAL DEFECT IN THE POSTERIOR ASPECT OF THE GREATER TROCHANTER. APPEARANCE SUGGEST ADVERSE TISSUE REACTION. IN THE APPROPRIATE CLINICAL CONTEXT INFECTION COULD HAVE A SIMILAR IMAGING APPEARANCE. CONSIDER ASPIRATION OF THE COLLECTION AND ANALYSI

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17058225 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: ON (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 17031093 ↗
• InjurySep 30, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH METAL ON METAL CONSTRUCT. SURGEON WAS UNSURE OF ORIGINAL IMPLANT DATE. PATIENT WAS DEALING WITH METALLOSIS AND THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM A HEAD AND LINER EXCHANGE. ONCE DISLOCATED, SURGEON CHECKED THE STEM AND FELT THE TRUNNION WAS WORN AND THE STEM NEEDED TO BE CHANGED. ALSO, THE PATIENT HAD A LOWER SPINE FUSION, SO HE FELT THE PATIENT WOULD BENEFIT FROM A DUAL MOBILITY CONSTRUCT. A NEW STEM WAS IMPLANTED AND THE DM WAS TRIALED. THE APPROPRIATE HEAD SIZE WAS SELECTED AND THE REAL IMPLANT WAS OPENED AND INSERTED. HIP WAS STABLE AND THE CLOSING PROCESS BEGAN. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT.

  Patient problems: Foreign Body Reaction

  MAUDE report 15511385 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 15216346 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD RECEIVED. LITIGATION ALLEGES THAT THE PATIENT WAS DIAGNOSED WITH DENSE FIBROUS TISSUE AND FOCAL SYNOVIUM WITH FOCI OF DEGENERATION, HEMORRHAGE, MILD CHRONIC LYMPHOHISTIOCYTIC INFLAMMATION, HEMOSIDEROSIS, METALLOSIS, RARE FOREIGN BODY GIANT CELLS, AND ABUNDANT FIBRIN OF THE RIGHT HIP BONE AND TISSUE. DOI: (B)(6) 2018. DOR: NOT REPORTED. RIGHT HIP. (B)(4) FIRST REVISION. (B)(4) SECOND REVISION. (B)(4) THIRD REVISION.

  Patient problems: Foreign Body Reaction; Impaired Healing; Necrosis; Osteolysis; Pain; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 14336243 ↗
• InjuryApr 20, 2022Osseointegration Problem; Osseointegration Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING OF THE FEMORAL STEM. FEMORAL STEM AND FEMORAL HEAD REVISED. DATE OF IMPLANT: (B)(6) 2015; DATE OF REVISION: (B)(6) 2019; (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 14159173 ↗
• InjuryApr 13, 2022Osseointegration Problem; Osseointegration Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING OF THE FEMORAL STEM, PAIN AND STIFFNESS. DATE OF IMPLANT: (B)(6) 2016, DATE OF REVISION: (B)(6) 2019, (RIGHT HIP). REVISION OF THE HEAD, STEM AND LINER.

  Patient problems: Inadequate Osseointegration; Muscular Rigidity; Pain

  MAUDE report 14103447 ↗
• InjuryApr 1, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  (B)(6) MOM LITIGATION RECORD RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FOR HEAVY METAL RELEASED RESULTING TO INJURY TO MUSCLE, TISSUES, SCAR TISSUE FORMATION, METAL WEAR , LIMITED ADL. AND PAIN. PLAINTIFF ALSO SUFFERED EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6) 2009; DOR: (B)(6) 2021 ; UNKNOWN HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Muscle/Tendon Damage; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 13976812 ↗