S-ROM 52-3194Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295170884), received between Apr 20, 2018 and Apr 6, 2026 — classified as 16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION. ALL IMPLANTS REMOVED AND ANTIBIOTIC SPACER IMPLANTED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24790058 ↗
• InjuryDec 2, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SURGEON REVISED FEMORAL COMPONENTS AND REPLACED WITH A COMPETITOR REVISION STEM. PATIENT HAD TRAUMA TO THE HIP AND THE STEM BECAME LOOSE. PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20825242 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR ORIGINAL COMPLAINT: LITIGATION ALLEGES THAT THE PATIENT SUFFERED SIGNIFICANT AND CHRONIC PAIN. UPDATE AD 31 DEC 2019: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PAINFUL PROSTHESIS DUE TO ELEVATED METAL LEVELS. OPERATIVE NOTE REPORTED HAVING SOME IMPINGEMENT ISSUE, CAPSULE HAD BROWNISH GRAYISH METALLIC STAINED FLUID AND PSEUDOCAPSULE WAS PRESENT. DOI: (B)(6) 2008. DOR: (B)(6) 2016, (LEFT HIP).

  Patient problems: Edema; Joint Disorder; No Code Available; Pain; Test Result

  MAUDE report 9590606 ↗
• InjuryOct 14, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE 9/30/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, A CORRECT DOR WAS PROVIDED. THE PATIENT WAS REVISED ON (B)(6) 2013 FOR INFECTION. ALL IMPLANTS WERE REMOVED AND SPACERS WERE PLACED. THE PATIENT WAS REIMPLANTED ON (B)(6) 2013 WITH COMPETITOR PRODUCTS. THE (B)(6) 2013 REVISION OPERATIVE NOTE INDICATED LOOSENING, BUT DIDN'T INDICATE WHICH PRODUCTS WERE LOOSE. LAB RESULTS WITHIN THE PFS INDICATED THE METAL ION LEVELS WERE LESS THAN 7PPB. AT THIS TIME INFECTION ISN'T ALLEGED PER THE LITIGATION. ALL OTHER PRODUCTS ARE BEING ADDED TO THE COMPLAINT, BUT PUT IN AS MDR NOS. PART/LOT IS BEING UPDATED FOR THE HEAD/LINER. UPDATE AD 13 SEP 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP AND STEM. AFTER RE-REVIEW OF MEDICAL RECORDS ATTACHED IN ETQ, REVISION NOTES DID NOT MENTION ANY LOOSENING. DOI: (B)(6) 2007 - DOR: (B)(6) 2013 (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain; Unspecified Infection

  MAUDE report 9185406 ↗
• InjuryAug 9, 2019Use of Device Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Migration; Use of Device Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Migration

  LITIGATION ALLEGES PAIN, INSTABILITY AND ELEVATED METAL ION LEVELS. MEDICAL RECORDS REPORTED PAIN WITH WEIGHT BEARING AN A RADIOGRAPH REPORTEDLY SHOWED MILD VARUS SHIFT OF THE FEMORAL COMPONENT SUGGESTING LACK OF INGROWTH AND SEVERE OSTEOPOROSIS. UPDATE AD 25 JUL 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND IMPLANT RECORD. PPF ALLEGES INFECTION, METALLOSIS AND METAL WEAR. UPDATED DOR, AGE, LAWYER AND LAW FIRM. ADDED IPS FOR THE PATIENT HARM. DOI: (B)(6) 2007 - DOR: (B)(6) 2018, (RIGHT HIP).

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

  MAUDE report 8879284 ↗
• InjuryJul 1, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PATIENT ALLEGES HE SUFFERS FROM PAIN, AS WELL AS HIS DOCTORS "CONCLUDING THAT HIS HIP IS MOVING IN PLACES IT'S NOT SUPPOSED TO MOVE." LEGAL CLAIM ALLEGES LOOSENING, BUT DOESN¿T INDICATE WHAT PRODUCTS ARE LOOSE. AFTER REVIEWING THE MEDICAL RECORDS, THE SURGEON INDICATED THE PATIENT'S STEM AND SLEEVE NEED BE REVISED. HE ALSO STATES THE PATIENT HAS HIGH METAL IONS. THE PATIENT HAS NOT BEEN REVISED YET. AFTER READING THE PRIMARY OPERATIVE NOTE, IT INDICATED AN ANTERIOR SPLIT OCCURRED WHILE INSERTED THE TRIAL SLEEVE. THE TRIAL HEAD WAS THEN PLACED AND ANOTHER FRACTURE OCCURRED ANTERIOR AND ANTEROMEDIALLY OCCURRED THROUGH THE CALCHAR AREA. THE UNKNOWN DEPUY HIP IS BEING CHANGED TO AN UNKNOWN TRIAL SLEEVE. A UNKNOWN STEM AND SLEEVE ARE BEING ADDED FOR THE ALLEGED LOOSENING, BUT NOT REPORTED AS THERE HASN¿T BEEN A REVISION OR SERIOUS INJURY. THE UNKNOWN HEAD AND LINER ARE BEING ADDED FOR THE ALLEGED HIGH METAL IONS, BUT NOT REPORTED AS THERE HASN¿T BEEN A REVISION OR SERIOUS INJURY. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM DISCOMFORT. A DOI AND DOR WERE PROVIDED. WE ARE NOW REPORTING THE HEAD AND LINER DUE TO GENERAL METAL ON METAL ALLEGATION

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

  MAUDE report 8747946 ↗
• InjuryFeb 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE PHYSICAL PAIN, BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY, AND HIGH LEVELS OF TOXIC METAL IN HER BLOOD STREAM. UPDATE SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METALLOSIS AND METAL WEAR. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS LEFT FAILED METAL ON METAL HIP ARTHROPLASTY. IT WAS ALSO CONFIRMED THAT THE PATIENT HAD ELEVATED METAL IONS. REVISION NOTES INDICATED THAT THE TRUNNION WAS NOTED TO HAVE METALLOSIS. DOI: (B)(4) 2008 - DOR: (B)(4) 2014, (LEFT HIP).

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

  MAUDE report 8347296 ↗
• InjuryDec 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED PAIN, SWELLING, INFLAMMATION, INFECTION, AND DAMAGE TO SURROUNDING BONE AND TISSUE, MULTIPLE DISLOCATIONS AND LACK OF MOBILITY. UPDATE 9/24/15: AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN, INSTABILITY, SUBLUXATION, AND DISLOCATION. DURING THE PRIMARY OPERATIVE NOTE CABLES WERE PLACED PROPHYLACTICALLY DUE TO POOR BONE QUALITY. THE PATIENT INDICATES THE CABLES WERE PLACED DUE TO A FRACTURE, BUT THERE IS NO INDICATION OF THAT. THERE WAS NO MENTION OF ANY INFECTION AS PREVIOUSLY ALLEGED. UPDATE AD 04 MAY 2018: RECEIPT OF PPF AND MEDICAL RECORDS. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION BUT THIS HAS BEEN REPORTED PREVIOUSLY. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. REVISION NOTES INDICATED THAT THE HIP WAS COMPLETELY DISLOCATED. THE CABLE THAT WAS PLACED AT HER PREVIOUS SURGERY SUSTAINED A FRACTURE OF THE PROXIMAL FEMUR. IT WAS ALSO NOTED THAT THE ILIOPSOAS TENDON HAD EVIDENCE OF TENDINITIS DUE TO IMPINGEMENT AGAINST THE CABLE. ADDED STEM DUE TO FRACTURE OF PROXIMAL FEMUR.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8195677 ↗
• InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES "PEUDOTUMOR", METALLOSIS, METAL WEAR, ELEVATED METAL IONS BEFORE FIRST REVISION.

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

  MAUDE report 8117216 ↗
• InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PSEUDOTUMOR, METALLOSIS, METAL WEAR, ELEVATED METAL IONS BEFORE FIRST REVISION.

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

  MAUDE report 8116859 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ELEVATED METAL IONS.

  Patient problems: Test Result

  MAUDE report 7995361 ↗
• InjuryOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS RECEIVED. PFS ALLEGES PAIN, TROUBLE WALKING, AND TROUBLE WITH DAILY ACTIVITIES. PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2010; DOR: (B)(6) 2014; (RIGHT HIP).

  Patient problems: Pain; Test Result

  MAUDE report 7991770 ↗
• InjuryOct 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEPUY 18-65. THE PATIENT WAS SUBJECTED TO A RIGHT HIP ARTHROPLASTY ON DATE (B)(6) 2008. IN THE FOLLOWING YEARS THE PATIENT ACCUSED PAIN AT THE FEMUR AND GROIN. IN (B)(6) 2018, THE PATIENT HAD A FEVERISH ATTACK, WITH STRONG PAIN IN THE GROIN AND BLOCK OF THE RIGHT LEG. ON (B)(6) 2018 THE PATIENT WAS HOSPITALIZED WITH DIAGNOSIS OF RIGHT COXALGIA WITH PHLOGOSIS. SUBSEQUENTLY IT WAS DETECTED HIGH IONS LEVELS OF CR-CO. IT WILL BE NECESSARY TO PERFORM A REVISION SURGERY. LEGAL RELATED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fever; Inflammation; Pain; Test Result

  MAUDE report 7966058 ↗
• InjurySep 25, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7906050 ↗
• InjuryMay 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE REC'D 5/7/15 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM DISCOMFORT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. UPDATE 8/28/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2015. UPDATE AD 1 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(6) DUE TO RECEIPT OF PPF AND STICKER SHEET RECORDS. PPF ALLEGES ELEVATED METAL IONS. THE EVENT DESCRIPTION HAS BEEN UPDATED TO INDICATE THE ALLEGATIONS AS REVIEWED. THE LAW FIRM NAME, MANUFACTURING DATE AND UDI, AND PATIENT HARM WERE UPDATED AS WELL. DOI: (B)(6) 2005; DOR: (B)(6) 2005; RIGHT HIP.

  Patient problems: Discomfort; No Code Available; Not Applicable; Pain; Test Result

  MAUDE report 7552507 ↗
• InjuryApr 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS GROIN PAIN, BONE INJURY, SOFT TISSUE INJURY, DISCOMFORT, AND METAL POISONING. DOI: (B)(6) 2010. DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Discomfort; Distress; Inflammation; Injury; No Code Available; Not Applicable; Pain; Tissue Damage

  MAUDE report 7446551 ↗