S-ROM 52-3291Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295170969), received between Jan 18, 2013 and Mar 19, 2021 — classified as 14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A NON UNION OF HER FEMORAL OSTEOTOMY (WHICH WAS PLATED DURING THE PREVIOUS SURGERY). THE STEM AND HEAD WERE EXTRACTED AND A LONG STEM WAS IMPLANTED TO HELP REDUCE FX WITH A NEW TRAUMA LATE/SCREWS. WE TRIALED THE HEAD AND IMPLANTED THE REAL HEAD ONCE IT WAS DECIDED TO BE THE CORRECT SIZE. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11527217 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT BEGUN EXPERIENCING RIGHT THIGH PAIN OVER TIME. HER PAIN WAS LOCALIZED OVER THE DALL-MILES CABLES AND HETEROTOPIC OSSIFICATION AT THE PROXIMAL 1/3 FEMORAL DIAPHYSIS. THE PATIENT PERFORMED A SURGERY ON ((B)(6) 2019) FOR RIGHT FEMUR REMOVAL OF HARDWARE AND EXCISION OF HETEROTOPIC OSSIFICATION. NO OTHER HIP IMPLANTS WERE REVISED. XRAY REPORTED MILD SURROUNDING SOFT TISSUE EDEMA. DOI: (B)(6) 2005; (STEM, SLEEVE, CUP, SCREW), DOI: (B)(6) 2018; (HEAD, LINER), DOR: NONE REPORTED; RIGHT HIP. PLEASE SEE (B)(4) FOR 1ST REVISION OF RIGHT HIP.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9883048 ↗
• InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED INFECTED LEFT TOTAL HIP ARTHROPLASTY. OPERATIVE NOTES INDICATED PUS AROUND THE PROSTHESIS. HE HAS BEEN BACK ON 3 OCCASIONS FOR DRAINAGE AND IT WAS PURULENT. DOI: (B)(6) 2009; DOR: (B)(6) 2009 (LEFT HIP).

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 9664838 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. 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 PSEUDOTUMOR, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2007; DOR: (B)(6) 2016 (LEFT HIP) FIRST REVISION. PATIENT IS BILATERAL PLEASE SEE (B)(4) FOR THE RIGHT HIP FIRST REVISION.

  Patient problems: Ambulation or Postural Difficulties; Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Hypoesthesia; No Code Available; Pain; Test Result

  MAUDE report 9293127 ↗
• InjuryFeb 19, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE 14X9 STEM BROKE INSIDE OF FEMORAL SLEEVE AFTER 26 YEARS. STEM WAS EXTRACTED, SLEEVE RETAINED IN PATIENT AND LONG 14X9 STEM WAS IMPLANTED. PATIENT HAS PINNACLE LINER THAT WAS REMOVED AND REPLACES WITH ALTRX LINER DOI: (B)(6) 1992; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 8349628 ↗
• InjuryJan 23, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE SLEEVE AND STEM AT BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8270379 ↗
• InjuryOct 15, 2018Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate

  PENDING PRODUCT LIABILITY, PFS ALLEGES PAIN, NEUROPATHY ON THE RIGHT FOOT, MUSCLE SPASM, AND MUSCLE ATROPHY. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS FAILED PAINFUL RIGHT TOTAL HIP ARTHROPLASTY. REVISION NOTES REPORTED THAT A FAIR AMOUNT OF BLOODY FIBROUS DEBRIS WAS CULTURED AND DEBRIDED. THE STEM WAS FOUND TO BE LOOSE AND BROKEN. INTRAOPERATIVE RADIOGRAPH SHOWED THAT PERFORATION HAD OCCURRED AT THE LATERAL CORTEX, SO AN ETO WAS PERFORMED. A CRACK WAS THEN NOTED AT THE DISTAL PART OF THE FEMUR, AND TWO CABLES WERE PASSED DISTALLY, AND ALSO TWO PROXIMALLY, TO REPAIR THE ETO.

  Patient problems: Fibrosis; Inadequate Osseointegration; Muscle Spasm(s); Neuropathy; No Code Available; Pain

  MAUDE report 7966390 ↗
• InjuryAug 8, 2018Fitting Problem; Migration; Fitting Problem; Migration

  STEM DISLOCATED DUE TO IMPLANT POSITIONING AND SIZING. UNDERSIZING ALLOWED FOR STEM TO MOVE, AND NOT FIXATE TO BONE.

  Patient problems: No Code Available

  MAUDE report 7762042 ↗
• InjuryJul 18, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  TOTAL HIP REVISION RELATED TO STEM LOOSENING.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7697847 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DER STATES THAT THIS PATIENT HAD HER RIGHT HIP REPLACED RECENTLY AND WEEKS AFTER BEGAN TO HAVE SOME DRAINAGE FROM HER WOUND. SHE HAD A CONSULTATION AND HIP ASPIRATION WHICH INDICATED THERE WAS MOST LIKELY AN INFECTION PRESENT. SURGEON BROUGHT THE PATIENT TO WILLIAM BEAUMONT TROY FOR AN I&D PROCEDURE. THE HIP BALL, STEM, AND LINER WAS EXPLANTED. THE 48MM SECTOR CUP AND SROM SLEEVE WAS LEFT IMPLANTED. THE WOUND AND JOINT WAS WASHED OUT AND NEW COMPONENTS WERE IMPLANTED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7609161 ↗
• InjuryApr 10, 2018Disassembly; Migration or Expulsion of Device; Disassembly; Migration or Expulsion of Device

  SROM REVISION, SURGEON: (B)(6) PRIVATE HOSPITAL (B)(6) 2018. SROM REVISION DUE TO DISLOCATION 5 YEARS AFTER INITIAL SURGERY. STEM DOES NOT SEEM TO HAVE ENGAGED WITH TAPER AND HAD COME LOOSE. SLEEVE WELL FIXED AND LEFT IN SITU. STEM WAS REVISED TO INCLUDE A 36 NECK OPTION AD POLY WAS EXCHANGED FOR A 36/52 NEUTRAL CUP WITH A 36 HEAD. PATIENT STABLE POST OP. RELEVANT PATIENT PRE-EXISTING CONDITIONS/ COMORBIDITIES: PREVIOUS DYSPLASTIC HIP WITH PELVIC OSTEOTOMY. MALE PATIENT, (B)(6). DOI:5 YEARS AGO; DOR: (B)(6) 2018 ; UNKNOWN HIP.

  Patient problems: Not Applicable

  MAUDE report 7412314 ↗
• InjuryFeb 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  RIGHT HIP REV DONE BY SURGEON. PATIENT COMPLAINED OF PAIN, ELEVATED ION LEVELS. REMOVED HEAD, LINER AND STEM. NO SURGICAL DELAY. NO BROKEN INSTRUMENTS. ORIGINAL DATE OF SURGERY IS (B)(6) 2009. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Code Available; Pain

  MAUDE report 7241240 ↗
• InjuryNov 16, 2017Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND HAS BROKEN STEM.

  Patient problems: No Information; Pain

  MAUDE report 7037492 ↗
• InjuryJan 18, 2013Fracture; Use of Device Problem; Malposition of Device; Osseointegration Problem

  LITIGATION ALLEGES PATIENT SUFFERS FROM SEVERE PAIN, DISCOMFORT, AND INFLAMMATION. LITIGATION ALSO ALLEGES LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PLAINTIFFS BLOOD, TISSUE, AND BONE. **UPDATE** (B)(4) 2012 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

  Patient problems: Bone Fracture(s); No Information

  MAUDE report 2922584 ↗