S-ROM 1365-47-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295033875), received between Jan 5, 2018 and Dec 12, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 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.

• InjuryDec 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED, THAT PATIENT WAS REVISED FOR DISLOCATION. SURGEON TOOK OUT THE STEM AND HEAD. AND SWAPPED FOR A LONGER STEM. NO HARM OCCURRED TO THE PATIENT. AND THERE WERE NO DELAYS. NO BROKEN INSTRUMENTS WERE FOUND. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20916390 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S HEAD EXCHANGE DUE TO INFECTION IN THE JOINT. NEGATIVE DISCUSSION OF DEPUY DID NOT OCCUR AS A RESULT OF SURGERY. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 17118500 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HIP WAS EXPLANTED FOR INFECTION. TEMPORARY SPACER WAS PUT IN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16488111 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL HIP. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16158074 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12232159 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED HIP; SURGEON EXPLANTED COMPONENTS AND IMPLANTED PROSTALAC SPACER. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10853718 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. HEAD AND LINER EXCHANGED. SAME SIZES USED. NOTHING FURTHER TO REPORT. DOI: UNKNOWN DOR: (B)(6) 2020 UNKNOWN HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10763894 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR UNSTABLE LEFT THA. DESCRIPTION OF PROCEDURE NOTED THAT ROM WAS GOOD AND STABILITY WAS GOOD WITH MINIMAL IMPINGEMENT. DOI: (B)(6) 2014; DOR; (B)(6) 2015; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9251017 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES DISTRESS AND LIMITED MOBILITY.

  Patient problems: Distress; Loss of Range of Motion; Test Result

  MAUDE report 8898258 ↗
• InjuryJul 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION. DOI: (B)(6) 2009, DOR: (B)(6) 2009, (LEFT HIP) 2ND REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8845846 ↗
• InjuryApr 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEET RECORDS RECEIVED AFTER FIRST REVISION. IN WHAT WERE PREVIOUSLY ALLEGED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION.

  Patient problems: Joint Dislocation

  MAUDE report 8503807 ↗
• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION AFTER THE FIRST REVISION. DOI: (B)(6) 2012 - DOR: (B)(6) 2012 ( RIGHT HIP). PLEASE SEE (B)(4) FOR THE FIRST REVISION. CUP, HOLE ELIMINATOR, SLEEVE, BONE SCREW, STEM: DOI: (B)(6) 2008 - DOR: NOT REVISED ( RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8398478 ↗
• InjuryOct 5, 2018Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT IRRIGATION AND DEBRIDEMENT WITH HEAD EXCHANGE WAS DONE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7938233 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI HEAD AND LINER: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7168219 ↗