S-ROM 52-3394Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295171003), received between Oct 9, 2018 and Jun 6, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD HIP DONE BY ANOTHER SURGEON SEVERAL YEARS AGO. THE STEM APPEARED TO BE LOOSE, SURGEON PLANNED TO REVISE THE STEM TO A ZIMMER BIOMET ARCOS. THE PINNACLE CUP AND ULTIMATE LINER WERE LEFT IMPLANTED. THERE WAS LOOSENING OF THE STEM. SALES REP WAS UNSURE OF THE LOT NUMBERS FOR EXPLANTED IMPLANTS. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14603138 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF, IMPLANT RECORDS AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AND INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2014 (HEAD & LINER); DOI: (B)(6) 2010 (CUP, SCREW, SLEEVE & STEM); DOR: (B)(6) 2015 LEFT HIP. SEE (B)(4) LEFT HIP 1ST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9158706 ↗
• InjuryApr 17, 2019Biocompatibility; Biocompatibility

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ELEVATED METAL ION LEVELS AFTER THE FIRST REVISION SURGERY.

  Patient problems: Test Result

  MAUDE report 8522574 ↗
• InjuryApr 1, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  NEW (B)(4) RECORD CREATED IN ORDER TO UPDATE (B)(4) (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. PATIENT WAS REVISED TO ADDRESS METALOSIS, OSTEOLYSIS, AND PAIN. UPDATE: LITIGATION PAPERS RECEIVED 12/4/2013. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM DISCOMFORT AND INFLAMMATION. UPDATE 1/28/2015 - DISC 208 PFS AND MEDICAL RECORDS RECEIVED. PFS IDENTIFIED PATIENT HEIGHT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. UPDATE AD 17 JUL 2018 -RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES PSEUDOTUMOR, METAL WEAR AND ELEVATED METAL IONS.

  Patient problems: Discomfort; Inflammation; No Code Available; Osteolysis; Pain; Test Result; Tissue Damage

  MAUDE report 8469035 ↗
• InjuryFeb 26, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: (B)(6) 2012 (LEFT HIP).

  Patient problems: Pain; Test Result

  MAUDE report 8369621 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES LOOSENING OF CUP AND INFECTION. DOI: (B)(6) 2009 - DOR: (B)(6) 2009 (RIGHT HIP).

  Patient problems: Not Applicable; Pain; Unspecified Infection; Weakness

  MAUDE report 7946753 ↗
• InjuryOct 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LITIGATION ALLEGES LOOSENING OF CUP AND INFECTION. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Pain; Unspecified Infection; Weakness

  MAUDE report 7946582 ↗