S-ROM 52-8323Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295171478), received between Jan 23, 2018 and Oct 16, 2019 — classified as 5 injuries, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION. DOI: (B)(6) 2018; DOR: NONE REVISED (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 9199236 ↗
• InjurySep 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AND PSEUDOTUMOR AFTER FIRST REVISION. DOI: (B)(6) 2017. DOR: NONE REPORTED; LEFT HIP. SEE (B)(4) LEFT HIP 1ST REVISION.

  Patient problems: Hypersensitivity/Allergic reaction; Joint Dislocation

  MAUDE report 9081988 ↗
• InjuryAug 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORDS RECEIVED . PPF ALLEGED DISLOCATION AFTER FIRST REVISION. MEDICAL RECORDS HAS NO OPERATIVE NOTE PROVIDED. DOI: (B)(6) 2014 - DOR: NONE REPORTED, (RIGHT HIP) (B)(4).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8888776 ↗
• InjuryJun 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND STICKER SHEETS RECEIVED. PPF HAS NO ALLEGATIONS REPORTED. DOI: (B)(6) 2004; DOR: NOT REPORTED; (RIGHT HIP).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7645942 ↗
• MalfunctionMay 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT THE NEW SROM ALUMINA/ TITANIUM 11/13 TAPER 32 MM HEADS HAVE GROSSLY INADEQUATE LABELING. IT WAS ALSO REPORTED THAT IT IS NOT LABELED TITANIUM SLEEVE OR ANYTHING INDICATING A SLEEVE. THE ONLY INDICATION IS ON THE UNDERSIDE WHICH NEXT TO METAL HAS A ''TI'' NEXT TO IT. DOE: (B)(6) 2018, RIGHT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7536911 ↗
• InjuryJan 23, 2018Fracture; Noise, Audible; Fracture; Noise, Audible

  DER STATES THAT ON (B)(6) 2017 PATIENT REPORTS NO FALL BUT IS UNABLE TO USE HER LEFT HIP. PRESENT TO THE ER AND IT WAS RADIOGRAPHICALLY DISCOVERED THAT THE PATIENT CERAMIC HEAD HAD FRACTURED. A DISTURBING SITUATION DISCOVERED WHILE THEY WAS TRYING TO BOOK THE NECESSARY REVISION COMPONENT TO HELP FIX THE LADIES HIP WERE THE UNAVAILABILITY OF A DURALOC POLY OPTION THUS REQUIRING THE SURGEON TO REMOVE A WELL FIX DURALOC CUP. ALONG WITH A CATASTROPHIC FAILURE OF THE CERAMIC COMPONENTS THE SURGEON HAS REPORTED THIS TO THE FDA. PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) ON (B)(6) 2017 AND ALL COMPONENTS EXCEPT FOR THE METAPHYSEAL SLEEVE REMOVED. THERE WAS EXTREME DIFFICULTY IN REMOVING THE CERAMIC LINER FROM THE DURALOC CUP. THEY ARE UNSURE IF THE FAILURE TO THE LINER WAS CAUSED PRIOR OR AFTER THE FAILURE OF THE HEAD. THE DURALOC CUP WA REMOVED WITH THE ZIMMER CUP OUT AND THE PATIENT WAS REVISED USING PRIMARY IMPLANTS. THE SURGEON CHOSE A METAL HEAD AND A POLY LINER. HE WAS ALSO GIVEN AN OPTION OF ANOTHER MORE CURRENT CERAMIC ON CERAMIC OPTION BUT DECIDED AGAINST IT. THEY TRIED TO FIND WHY THE POLY WAS NOT AVAILABLE, THEY SPOKE WITH THE AREA VICE PRESIDENT. HE WAS ABLE TO FIND OUT THAT

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable; Pain

  MAUDE report 7211791 ↗