Remedy Spacer RHHDMDRecalls & reported problems
Osteoremedies, LLC · Remedy Modular Head 54mm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00855195006265), received between Jul 27, 2017 and Jul 27, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment Of Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Detachment Of Device Component2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2017Detachment Of Device Component; Detachment Of Device Component
SEVEN DAYS POST-OPERATIVE THE PATIENT WAS RISING FROM A SITTING POSITION AND HEARD A SOUND IN THEIR HIP. THE PATIENT WENT TO THE DOCTOR AND IT WAS IDENTIFIED THAT THE FEMORAL HEAD HAD DISASSOCIATED FROM THE FEMORAL STEM. A REVISION SURGERY WAS PERFORMED AND THE SPACER WAS REPLACED WITH A NEW SPACER.
Patient problems: Failure of Implant
MAUDE report 6747113 ↗InjuryJul 27, 2017Detachment Of Device Component; Detachment Of Device Component
SEVEN DAYS POST-OPERATIVE, THE PATIENT WAS RISING FROM A SITTING POSITION AND HEARD A SOUND IN THEIR HIP. THE PATIENT WENT TO THE DOCTOR AND IT WAS IDENTIFIED THAT THE FEMORAL HEAD HAD DISASSOCIATED FROM THE FEMORAL STEM. A REVISION SURGERY WAS PERFORMED AND THE SPACER WAS REPLACED WITH A NEW SPACER.
Patient problems: Failure of Implant
MAUDE report 6747070 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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