S-ROM 56-3514Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295178187), received between May 17, 2018 and Sep 14, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Osseointegration Problem

  It was reported that patient had pain in hip. Lucency around sleeve. There was loosening of Sleeve and stem at unknown interface with unknown cement manufacturer. Stem looked tight distal. Stem, Sleeve, Head, and Poly were removed. Reclaim Monobloc Short Stem was implanted and poly was changed to a 10 degree.Affected Side: Right Hip.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 50754173 ↗
• InjuryNov 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE S-ROM STEM WAS BROKEN AT THE STEM/SLEEVE INTERFACE. REFERENCE AND LOT NUMBER FOR EXPLANTED PINNACLE CUP NOT AVAILABLE. DOI: (B)(6) 2009. DOR: (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 23477797 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2005 PATIENT DEVELOPED A DEEP VEIN THROMBOSIS POSTOPERATIVELY. DOI: (B)(6) 2005; DOE: (B)(6) 2005; RIGHT HIP; THIS (B)(4) IS A LINK OF (B)(4).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17070109 ↗
• InjuryAug 18, 2021Fracture; Fracture

  THE PATIENT WAS REVISED DUE TO A BROKEN S-ROM STEM. SURGEON EXTRACTED SROM COMPONENTS AND PINNACLE LINER REVISING WITH COMPETITOR STEM. DOI: 2015, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 12337732 ↗
• InjurySep 29, 2020Degraded; Degraded

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT REPRESENT WITH INCREASE PAIN AND DISCOMFORT. COBALT AND CHROMIUM LEVELS WERE ELEVATED, A METAL SUBTRACTION MRI SHOWED A LARGE FLUID COLLECTION, CONSISTED WITH ADVERSE TISSUE REACTION. THE PATIENT WAS THEN REVISED FOR FAILED RIGHT METAL ON METAL THA. OPERATIVE NOTES REPORTED THAT THERE WAS ABOUT 60 CC OF GRAYING FLUID EMANATED FROM WHAT APPEARED TO BE A PSEUDOTUMOR CONSISTENT WITH ADVERSE TISSUE REACTION. SOME NECROTIC APPEARING MATERIAL WAS DEBRIDED. THERE WAS SOME EVIDENCE OF MEMBRANE FORMATION AT THE METAL INTERFACES CONSISTENT MORE WITH METAL ON METAL REACTION VS POLYETHYLENE OSTEOLYSIS. THERE WAS A SIGNIFICANT AMOUNT OF BLACKISH CORROSION AT THE FEMALE PORTION OF THE FEMORAL HEAD. THERE WAS SOME CORROSION ON THE TAPER. DOI: (B)(6) 2009; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Discomfort; Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; No Code Available; Osteolysis; Pain; Test Result; Tissue Damage

  MAUDE report 10599812 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS METALLOSIS. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN AND DIFFICULTY AMBULATING. THERE IS NO NEW INFORMATION THAT WOULD AFFECT THE MDR DECISION. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS AND METAL WEAR. DOI: (B)(6) 2003 - DOR: (B)(6) 2014 (LEFT HIP).

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

  MAUDE report 9129071 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS GROIN AND THIGH PAIN. PPF ALLEGES ELEVATED METAL IONS. DOI (B)(6) 2007, DOR (B)(6) 2012, (LEFT HIP).

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result

  MAUDE report 8971814 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, NUMBNESS, LIMITED MOBILITY AND DIFFICULTY BEARING WEIGHT. AFTER REVIEW OF THE MEDICAL RECORDS THE REVISION OPERATIVE NOTE REVEALED THE CUP WAS ANTEVERTED TOO MUCH AND WAS REPLACED. THE CUP IS BEING REPORTED FOR MALPOSITIONING. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS, METAL WEAR AND METALLOSIS. DOI: (B)(6) 2007 - DOR: (B)(6) 2013 (RIGHT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Hypoesthesia; Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result

  MAUDE report 8971369 ↗
• InjuryAug 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. LINER WAS NON DEPUY. DOI: (B)(6) 2013 - DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Test Result

  MAUDE report 8922914 ↗
• InjuryNov 20, 2018Fracture; Fracture

  LITIGATION RECORDS ALLEGES INJURY, WALKING DIFFICULTY, MENTAL AND PHYSICAL ANGUISH, SEVERAL EMOTIONAL DISTRESS AND DEPRESSION RELATING TO TRAUMA OF THE INJURIES. DOI: (B)(6) 2005. DOR: (B)(6) 2018. RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Distress; Limb Fracture; No Code Available; Pain

  MAUDE report 8089489 ↗
• InjuryMay 17, 2018Fracture; Loose or Intermittent Connection; Fracture; Loose or Intermittent Connection

  AFTER REVIEW OF THE MEDICAL RECORDS ON 3 JUL 2018, IT WAS DISCOVERED THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2013 DUE TO LOOSENING OF THE STEM AND SLEEVE AS WELL AS A GREATER TROCHANTER FRACTURE. A LESSER TROCHANTER FRACTURE WAS DISCOVERED DURING THE SECOND REVISION ON (B)(6) 2018. THERE IS NO EVIDENCE THE STEM AND SLEEVE WERE REMOVED DURING THE FIRST REVISION SURGERY ON (B)(6) 2018.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Not Applicable; Pain

  MAUDE report 7521653 ↗