S-ROM 52-3193Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295170877), received between Nov 4, 2017 and Dec 5, 2024 — classified as 32 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (7 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED, THAT THE ITEMS WERE EXPLANTED AND REVISED, DUE TO DISLOCATION. THERE WAS POTENTIAL MALPOSITIONING AND POTENTIAL PATIENT NON-COMPLIANCE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20851995 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Limb Fracture

  MAUDE report 17584272 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. NO ADDITIONAL DETAILS. NO SURGICAL DELAY. DOI: (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 15439678 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD PRIMARY TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2021 (SROM WITH PINNACLE CUP IMPLANTED). PATIENT PRESENTED WITH END STEM THIGH PAIN. THE PATIENT WAS REVISED ON (B)(6) 2022. STEM AND HEAD REMOVED AND REPLACED ¿ SLEEVE, CUP AND LINER REMAIN IN SITU. DOI: (B)(6) 2021, DOR: (B)(6) 2022, UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 15282478 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FEMUR FRACTURE DISTAL TO THE STEM. SWITCH TO LONGER STEM. DOI: (B)(6) 2016 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Limb Fracture

  MAUDE report 12215391 ↗
• MalfunctionMar 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 18X13X160 36 STD NECK SROM STEM WOULD NOT GO DOWN CANAL. THE SURGEON PULLED STEM OUT REAMED UP TO 14MM TRIED AGAIN AND THE STEM WAS STILL GETTING STUCK DURING INSERTION ABOUT 1/3 OF THE WAY DOWN. WE OPENED A 18X13X160 30 STD STEM AND THAT DID SEAT ALL THE WAY. THERE WAS A SURGICAL DELAY OF 10 MINUTES. DOE: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11582470 ↗
• InjuryOct 14, 2020Degraded; Degraded

  PINNACLE MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS PAIN AND SYNOVITIS. REVISION NOTES STATED THAT A BULGING THICKENED HIP CAPSULE WAS NOTED. A 10CC OF DARK RED PARTICULATE FLUID WAS REMOVED FROM THE JOINT AND DARK RED BROWN EFFUSION WAS EVACUATED. THE HEAD AND LINER WERE REMOVED. THERE WAS MODERATE AMOUNT OF TRUNNIONOSIS AND CORROSION OF THE FEMORAL TRUNNION. OPERATIVE FINDINGS NOTED METALLOSIS WITH MARK EFFUSION, LARGE PSEUDOTUMOR, AND OSTEOLYSIS. BLOOD COBALT LEVELS WERE INCREASING BUT LESS THAN 7 PPB. CLINIC VISITS NOTED EROSIONS OF PROXIMAL FEMUR. DOI: (B)(6) 2006 - DOR: (B)(6) 2020 (LEFT HIP).

  Patient problems: Edema; Erosion; Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Pain; Swelling; Synovitis

  MAUDE report 10676893 ↗
• InjuryApr 13, 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 ADVERSE LOCAL TISSUE REACTION AND OSTEOLYSIS, WITH HIGH BLOOD COBALT LEVELS (LEFT HIP). TREATMENT: REVISION OF METAL LINER AND METAL HEAD.

  Patient problems: Foreign Body Reaction; No Code Available; Osteolysis; Test Result

  MAUDE report 9953570 ↗
• InjuryMar 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS A FAILED LEFT TOTAL HIP METAL ON METAL ARTHROPLASTY WITH METALLOSIS AND PSEUDOTUMOR FORMATION. INTRAOPERATIVELY, CLEAR FLUID WAS SUCTIONED FROM THE JOINT. BLACK AND GREY METALLOSIS TISSUE WAS NOTED AROUND THE FEMORAL STEM AND CUP. THERE WAS NO OBVIOUS SIGN OF INFECTION. BOTH THE STEM AND CUP HAD NO SIGNS OF LOOSENING. THERE WAS NO EVIDENCE OF TRUNNION WEAR OR METALLOSIS INSIDE THE HEAD. ESTIMATED BLOOD LOSS WAS GREATER THAN 1000CC. PATIENT WAS GIVEN 1 UNIT OF PACKED RED BLOOD CELLS. DOI: (B)(6) 2010. DOR: (B)(6) 2018, (LEFT HIP).

  Patient problems: Edema; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 9776415 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL HIP REPLACEMENT. REASON FOR REVISION: LEG LENGTH DISCREPANCY. POST OP WAS DEEMED TO BE SHORT. PRE-OP PLANNING BY 360 PLANNING SYSTEM, REFLECTED SAME. ORIGINAL STEM WAS REMOVED . SCAR TISSUE WAS EXCISED . IMPLANTED 18/13 WITH 42 NECK, ALSO IMPLANTED +6 HEAD . INCREASED LEG LENGTH AND OFFSET.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9587517 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) HAS INDICATED THAT AFTER THE REVISION, THE PATIENT HAS NOTED A LEG LENGTH DISCREPANCY AND PAIN. THE MEDICAL RECORDS BELIEVE THE PAIN CAN BE ATTRIBUTED TO POSSIBLE LYMPHOMA. IN ADDITION PPF ALLEGES ELEVATED METAL IONS AFTER 1ST REVISION. DOI: (B)(6) 2014; DOR: NONE REPORTED; LEFT HIP.

  Patient problems: Pain; Test Result

  MAUDE report 9395633 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, NO REVISION NOTES PROVIDED. DOI: (B)(6) 2013 (HEAD AND LINER); DOR: NONE REPORTED (LEFT HIP); DOI: (B)(6) 2007 (STEM). THIS PC IS FOR THE ALLEGATIONS AFTER FIRST REVISION OF THE LEFT HIP. SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Test Result

  MAUDE report 9202231 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, NO REVISION NOTES PROVIDED. LINER WAS POLYETHYLENE. DOI: (B)(6) 2013 (HEAD); DOR: NONE REPORTED (RIGHT HIP); DOI: (B)(6) 2008 (STEM). THIS PC IS FOR THE ALLEGATIONS AFTER FIRST REVISION OF THE RIGHT HIP. SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Test Result

  MAUDE report 9202210 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, S-ROM HIP WAS PUT IN. THE PATIENT HAS HAD PAIN IN HIP. NOT SURE IF INFECTED. I&D WAS DONE AND PUT IMPLANTS BACK IN. DOI: (B)(6) 2019. DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9145098 ↗
• InjuryOct 1, 2019Corroded; Degraded; Corroded; Degraded

  PATIENT EXPERIENCED LOSS OF BONE AND LOSS OF MUSCLE.

  Patient problems: Deformity/ Disfigurement; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; No Code Available; Pain; Test Result; Unspecified Tissue Injury

  MAUDE report 9141684 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, FLUID COLLECTION AND DIFFICULTY AMBULATING. UPDATE 08 AUG 2018 (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF, IMPLANT RECORDS AND STICKER SHEETS. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. ALSO ADDED STEM IN IMPACTED PRODUCT DUE TO ALLEGED HIGH METAL IONS. DOI: (B)(6) 2010, DOR: (B)(6) 2012, LEFT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Inflammation; No Code Available; Pain; Test Result

  MAUDE report 8940161 ↗
• InjuryAug 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF THE MEDICAL RECORDS, THE METAL ION LEVEL PROVIDED WERE NOT ELEVATED.

  Patient problems: Discomfort; Foreign Body Reaction; Inflammation; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 8905704 ↗
• InjuryApr 3, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2010 - DOR: (B)(6) 2011, (RIGHT HIP).

  Patient problems: Pain; Test Result; Tissue Damage

  MAUDE report 8477951 ↗
• InjuryMar 29, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES METAL WEAR, ABDUCTOR MUSCLE REPAIR AND ELEVATED METAL IONS. DOI: (B)(6) 2006; DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Inflammation; Necrosis; Pain; Test Result; Tissue Damage

  MAUDE report 8463821 ↗
• InjuryMar 13, 2019Biocompatibility; Biocompatibility

  THE PATIENT WAS REVISED FOR METALLOSIS AND PAIN. UPDATE AD 13 JUL 2018: RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8416260 ↗
• InjuryMar 1, 2019Loss of Osseointegration; Loss of Osseointegration

  EMAIL NOTIFICATION RECEIVED CONTAINING PATIENT'S CLAIM. IT WAS REPORTED THAT THE PATIENT'S ASR IMPALNTS WERE REVISED TO ADDRESS LOOSENING. LOOSENING COMPONENT AND INTERFACE IS UNKNOWN.. DOI: 2012, DOR: (B)(6) 2018, LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8383680 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PSEUDOTUMOR AND ELEVATED METAL IONS AFTER FIRST REVISION. LINER WAS ALREADY REPORTED IN FIRST PC. DOI: (B)(6) 2010, DOR: (B)(6) 2012, (LEFT HIP).

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

  MAUDE report 8377987 ↗
• InjuryJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS METAL ON METAL INDUCED OSTEOLYSIS. UPDATE REVIEW OF OPERATIVE NOTE CONFIRMED OSTEOLYSIS. UPDATE MEDICAL RECORDS REPORTED METALLOSIS AND SYNOVITIS. UPDATE PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2006 - DOR: (B)(6) 2010 (LEFT HIP).

  Patient problems: No Code Available; Synovitis; Test Result; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 8285574 ↗
• InjuryJan 9, 2019Biocompatibility; Biocompatibility

  PATIENT WAS REVISED TO ADDRESS PAIN. LITIGATION ALLEGES DISCOMFORT AND DIFFICULTY AMBULATING. UPDATE AD 14 MAY 2018 RECEIPT OF PPF AND IMPLANT RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP, METAL WEAR AND ELEVATED METAL IONS.

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

  MAUDE report 8230845 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS BEFORE FIRST REVISION.

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

  MAUDE report 8223457 ↗