S-ROM 52-3293Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295170983), received between Oct 10, 2017 and Sep 6, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2000, THE PRIMARY SURGERY WAS PERFORMED VIA THA WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY, THE PATIENT REPEATEDLY DISLOCATED. THE EVENT DATE IS UNKNOWN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, TO REMOVE THE STEM, THE LINER AND THE SCREWS OF THE CUP. AFTER THE TRIAL, THE LINER, THE STEM AND THE HEAD WAS REPLACED. THE REASON FOR THE REVISION IS DISLOCATION DUE TO IMPINGEMENT. DOI: (B)(6) 2000. DOR: (B)(6) 2023. UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 17689366 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING SOME PAIN IN THEIR HIP. THOUGHT THE HEAD WAS WEARING THROUGH THE POLY. UPON EXAMINATION, THE HEAD WAS WEARING ON THE SIDE OF THE POLY. THE S ROM 18X13X160 30 STD STEM WAS REMOVED AND VERSION WAS CHANGED IN THE STEM. SURGEON WOULD LIKE TO HAVE POLY EXAMINED TO SEE IF ANY MANUFACTURES ISSUES. DOI: (B)(6) 2017, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10314665 ↗
• InjuryJun 15, 2020Fracture; Loss of Osseointegration; Device Dislodged or Dislocated; Fracture; Loss of Osseointegration; Device Dislodged or Dislocated

  THE PATIENT WAS IN PAIN AND HAD DEVELOPED A LIMP. PRIMARY IMPLANT DATE: (B)(6) 2005. REVISING A PINNACLE ASR/SROM THE SURGEON DISCOVERED THE NECK (36 + 12MM) HAD BENT AND DISCONNECTED FROM THE STEM. THE ORIGINAL PLAN WAS TO REPLACE THE LINER AND HEAD FROM METAL ON METAL ARTICULATION TO A POLY/CERAMIC OR CERAMIC/CERAMIC. AFTER OPENING THE SURGEON NOTED THAT THE STEM WAS LOOSE. THE NECK OF THE SROM STEM WAS DISCONNECTED FROM THE STEM AND SLEEVE. THEY REPLACED THE STEM WITH A SIZED 11 CORAIL KHO THE SURGEON WAS ABLE TO PULL IT OUT WITH HIS HAND. REP PRESENT. MALE PATIENT, ID: (B)(6), DOB: (B)(6), (B)(6)YEARS OLD. NO DELAY IN THE SURGERY.

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

  MAUDE report 10155104 ↗
• InjuryMay 20, 2019Fracture; Fracture

  CLINICAL NOTIFICATION RECEIVED FOR REVISION FOR PERIPROSTHETIC FEMUR FRACTURE DOI: (B)(6) 2019, DOR: (B)(6) 2019.

  Patient problems: Joint Disorder; No Code Available

  MAUDE report 8623262 ↗
• InjuryJul 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP AND INFECTION. DOI: (B)(6) 2007-DOR: NOT REPORTED (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 7710933 ↗
• InjuryJul 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION :LITIGATION RECEIVED . LITIGATION ALLEGES PAIN, DISCOMFORT, CLICKING NOISE, LIMITATION OF MOTION, AND SWELLING. NO PART AND LOT INFORMATION PROVIDED. UPDATE AD 23 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS. REVISION NOTES REPORTED OF NON-UNION WITH PROXIMAL RETRACTION OF THE GREATER TROCHANTER. THERE WAS SOME GRAY AND METAL STAINED, A MODERATE AMOUNT OF DARK METAL STAINING AND APPARENT PSEUDOTUMOR FORMATION ABOUT THE JOINT. THE S-ROM STEM WAS LOOSENED FROM THE SLEEVE AND EASILY REMOVED. SCAR TISSUE WERE REMOVED FROM THE BONY ENDS OF THE FRACTURE. SURGICAL PATHOLOGY REPORTED OF PSEUDOTUMOR OF RIGHT HIP. CLINICAL VISITS REPORTED OF DIFFICULTY IN AMBULATING. LABORATORY RESULT FOR METAL IONS WERE ABOVE 7PPB. ADDED STEM DUE TO ELEVATED METAL IONS. UPDATED DOI, DOR, PATIENT HARM, MEDICAL HISTORY, LABS AND PRODUCT DETAILS. DOI: (B)(6) 2008 - DOR: (B)(6) 2017 (RIGHT HIP).

  Patient problems: Discomfort; Loss of Range of Motion; No Code Available; Pain; Swelling; Test Result; Tissue Damage

  MAUDE report 7690047 ↗
• InjuryOct 10, 2017Difficult to Remove; Difficult to Remove

  THE PATIENT WAS REVISED TO ADDRESS WEAR OF THE LINER.

  Patient problems: No Information

  MAUDE report 6933812 ↗