S-ROM 1365-62-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295034094), received between Jan 23, 2018 and Sep 29, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 6 SEP 2022. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO PAINFUL LEFT METAL ON METAL. OPERATIVE NOTES INDICATES A LARGE EFFUSION OF CLEAR JOINT FLUID WAS RELEASED. SOME NECROTIC TISSUE ALONG THE INFEROMEDIAL HIP WAS NOTED. DOI: (B)(6) 2009 , DOR: (B)(6) 2016, LEFT HIP. PLEASE SEE (B)(4) FOR RIGHT HIP

  Patient problems: Anxiety; Depression; Discomfort; Fatigue; High Blood Pressure/ Hypertension; Itching Sensation; Metal Related Pathology; Necrosis; Pain; Swelling/ Edema

  MAUDE report 15504339 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS INFECTION. PAIN AND SWELLING WERE ALSO NOTED. REVISION NOTES REPORTED GROSS PURULENCE; NO METALLOSIS, SIGNIFICANT WEAR NOR METAL DEBRIS WERE FOUND. IT WAS STATED THAT THE PATIENT HAD A SUPERFICIAL INFECTION IN HIS ARM THAT SUBSEQUENTLY SPREAD TO HIS HIP. IT WAS ALSO NOTED THAT POST INITIAL HIP REPLACEMENT, THE PATIENT WAS ADMITTED DUE TO POST OP INFECTION DUE TO A SUPERFICIAL WOUND INFECTION THEN WAS TREATED WITH I&D AND 3 WEEKS OF IV ANTIBIOTICS. DOI: (B)(6) 2009; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 9627655 ↗
• InjuryNov 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain; Tissue Damage

  MAUDE report 8052373 ↗
• InjuryJan 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  INFECTED HIP WASHOUT. METAL LINER AND HEAD REMOVED AND REPLACED WITH ALTREX LINER AND METAL HEAD. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Unspecified Infection

  MAUDE report 7211837 ↗