S-ROM 52-3422Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295171058), received between Jun 29, 2017 and May 17, 2024 — classified as 15 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS A RIGHT TOTAL HIP REPLACEMENT DUE TO SEVERE, DEGENERATIVE ARTHRITIS. PATIENT WAS REVISED TO ADDRESS PAIN AND INFECTED HIP. ASR CONSTRUCT REVISED. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING AT THE BONE TO IMPLANT INTERFACE. DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Pain; Unspecified Infection

  MAUDE report 19339765 ↗
• InjuryDec 15, 2021Degraded; Degraded

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP TO ADDRESS HIP DISLOCATION AND POLYETHYLENE LINER WEAR. DATE OF IMPLANTATION: (B)(6) 2002. DATE OF REVISION: (B)(6) 2021. (RIGHT HIP). TREATMENT: REVISION OF ACETABULAR LINER AND FEMORAL HEAD.

  Patient problems: Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 13013862 ↗
• InjurySep 1, 2021Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS LYSIS AROUND THE PROXIMAL SECTION OF THE FEMORAL COMPONENT. IT WAS DIFFICULT TO REMOVE AND IT FELT LIKE THE FEMORAL COMPONENT WAS "WIDESCREEN WIPERING" IN THE FEMUR.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 12407418 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, LITIGATION REPORTED THAT THE PLAINTIFFS REVISION INVOLVED, IN PART, A FINDING OF AN ADVERSE TISSUE REACTION RELATED TO THE METAL-ON-METAL ARTICULATION, RELEASE OF A LARGE AMOUNT OF BROWNISH FLUID, AND DEBRIDEMENT AND REMOVAL OF BROWNISH FRIABLE TISSUE THROUGHOUT THE ENTIRE HIP JOINT, ALL DUE TO TOXIC HEAVY METAL/METAL ION COBALT AND CHROMIUM POISONING.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Arrhythmia; Depression; Discomfort; Distress; Dyspnea; Extraskeletal ossification; Fall; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Limb Fracture; Loss of Range of Motion; Muscle/Tendon Damage; Numbness; Pain; Paresthesia; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 11814330 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN SECONDARY TO POSSIBLE INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10504857 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FAILED RIGHT METAL ON METAL TOTAL HIP ARTHROPLASTY WITH METALLOSIS. OPERATIVE NOTES INDICATED PAIN, ELEVATED COBALT AND CHROMIUM LEVELS. THERE WAS ABUNDANT SCAR TISSUE AROUND THE JOINT THAT WAS DEBRIDED. EVIDENCE OF METALLOSIS WITH SOME BROWN STAINING OF TISSUE IN THE SYNOVIUM AND FLUID IN THE JOINT. THERE WERE NO SIGNS OF INFECTION. DOI: (B)(6) 2006, DOR: (B)(6) 2015, (RIGHT HIP).

  Patient problems: Adhesion(s); Edema; Foreign Body Reaction; No Code Available; Pain; Test Result

  MAUDE report 9856861 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED BECAUSE OF PAIN. UPDATE REC'D 9/19/2014 - LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN. UPDATE 21 AUG 2018 (B)(4) HAS BEEN RE-OPENED DUE TO RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PPF ALLEGED ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, NO REVISION NOTES REPORTED. DOI: (B)(6) 2003. DOR: (B)(6) 2013; LEFT HIP.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 9134365 ↗
• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR ORIGINAL COMPLAINT.- LITIGATION PAPERS ALLEGE THE PATIENT WAS REVISED ON IN (B)(6) OF 2008 AND AGAIN ON (B)(6) 2010. ORIGINAL LITIGATION INDICATED THAT THE PATIENT WAS IMPLANTED WITH ASR; HOWEVER, AMENDED LITIGATION ALLEGES THAT THE PATIENT WAS IMPLANTED WITH PINNACLE. LITIGATION ALLEGES PAIN AND MOBILITY ISSUES. THE REVISION OPERATIVE NOTE INDICATED PAIN AND NO METALLOSIS. THE STEM WAS REVISED SO THE ACETABULAR COMPONENT WAS ABLE TO BE VISUALIZED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS AND METAL WEAR. STEM HAS BEEN ADDED DUE TO THE ALLEGED BLOOD HEAVY METAL INCREASED. DOI: (B)(6) 2002; DOR: (B)(6) 2011; LEFT HIP. PATIENT HAS BILATERAL HIP IMPLANTS.

  Patient problems: Loss of Range of Motion; No Code Available; Pain; Test Result

  MAUDE report 8717744 ↗
• InjuryFeb 7, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN, LEG LENGTH DISCREPANCY, SYNOVITIS. UPDATE PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2009; DOR: (B)(6) 2012; (LEFT HIP).

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

  MAUDE report 8315891 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2003 - DOR: (B)(6) 2011 (RIGHT HIP).

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

  MAUDE report 8267365 ↗
• InjuryDec 17, 2018Loss of Osseointegration; Biocompatibility; Loss of Osseointegration; Biocompatibility

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM LARGE AMOUNTS OF TOXIC AMOUNTS OF COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENTS BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. IT IS ALSO ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND WEAKNESS. UPDATE AD 04 MAY 2018: RECEIPT OF PPF AND MEDICAL RECORD. PPF ALLEGES LOOSENING OF STEM. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED TOTAL HIP ARTHROPLASTY. ADDED STEM DUE TO ALLEGED LOOSENING OF STEM.

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain; Test Result; Weakness

  MAUDE report 8168750 ↗
• InjurySep 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF ALLEGES STROKE/HEART ATTACK AFTER REVISION. NO REVISION NOTE PROVIDED. DOI: (B)(6) 2011; DOR: NONE REPORTED; (RIGHT HIP).

  Patient problems: Infarction, Cerebral; Myocardial Infarction

  MAUDE report 7890193 ↗
• InjuryJul 17, 2018Loss of Osseointegration; Loss of Osseointegration

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, IMMOBILITY, INFLAMMATION AND HIGH LEVELS OF CHROMIUM AND COBALT. UPDATE AD (B)(6) 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS AND LOOSENING OF STEM. UPDATED PRODUCT AND LOT NUMBER OF INSERT (121887356/2136865), HEAD ( 136531000/2193018), STEM ( 523422/2160316), CUP (121722056/A5WFX1000).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Loss of Range of Motion; Pain; Test Result; Unspecified Infection

  MAUDE report 7694694 ↗
• InjuryJul 16, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS AND LOOSENING OF STEM. IT WAS ALSO INDICATED IN STICKERS SHEETS THAT PINNACLE SECTOR II ACETABULAR CUP, PINNACLE CANCELLOUS BONE SCREW, S-ROM TOTAL HIP SYSTEM FEMORAL STEM STANDARD, AND S-ROM TOTAL HIP SYSTEM ZTT PROXIMAL SLEEVE WERE IMPLANTED ON (B)(6) 2006. DOI: (B)(6) 2006 - DOR: (B)(6) 2010 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Not Applicable; Unspecified Infection

  MAUDE report 7689481 ↗
• InjuryJun 29, 2017Loss of Osseointegration; Loss of Osseointegration

  JUN 1, 2017. LEGAL MEDICAL RECORDS RECEIVED. LITIGATION ALLEGES PAIN IN PATIENT'S HIPS AND THIGHS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS MECHANICAL FAILURE OF RIGHT THR SECONDARY TO RECURRENT FEMORAL LOOSENING AND HETEROTOPIC OSSIFICATION. THERE WAS NO SIGNIFICANT SYNOVITIS OR CLINICALLY OBVIOUS SIGN OF INFECTION. THERE IS HETEROTOPIC OSSIFICATION AROUND THE FEMORAL ACETABULAR COMPONENTS, WHICH WAS EXTENSIVELY DEBRIDED. THERE WAS NO OVERT SIGN OF METALLOSIS, NO PSEUDOTUMOR. THE LEG LENGTH WAS FOUND TO BE SIGNIFICANTLY SHORT BY APPROX. 1 INCH WHICH WAS EQUALIZED. THE FEMORAL STEM WAS FOUND TO BE GROSSLY LOOSE AND WAS REMOVED. LABORATORY RESULT FOR COBALT CHROMIUM ARE BELOW 7 UG/L.

  Patient problems: Pain

  MAUDE report 6677902 ↗