RHEAD RCN-S3Recalls & reported problems
Stryker GmbH · Bipolar stem Implant, Size 3 · Class 2 · Implant
All models of RHEAD (12)
Data updated Oct 16, 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 00886385025162), received between Apr 14, 2020 and Apr 21, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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 16, 2026.
Most reported problems
Device problems
- Loss of Osseointegration2
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant2
- Injury2
- Loss of Range of Motion2
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2020Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT ALLEGEDLY FOLLOWING HER REPLACEMENT SURGERY THE PATIENT BEGAN TO EXPERIENCE INCREASING PAIN AND DECREASED FUNCTION IN HER ELBOW AND HER SURGEON CONFIRMED LOOSENING OF THE RADIAL HEAD PROSTHESIS. IT IS FURTHER ALLEGED THAT DURING THE REVISION SURGERY ON (B)(6) 2015 THE SURGEON FOUND THE RADIAL HEAD COMPONENT TO HAVE DISLOCATED/DISASSOCIATED FROM THE RADIAL STEM. ALLEGEDLY THE RADIAL HEAD COMPONENT WAS REVISED WITH ANOTHER STRYKER RADIAL HEAD COMPONENT.
Patient problems: Failure of Implant; Injury; Loss of Range of Motion; Pain
MAUDE report 9981155 ↗InjuryApr 14, 2020Loss of Osseointegration; Loss of Osseointegration
IT'S REPORTED THAT THE PATIENT UNDERWENT A RIGHT STRYKER LATERAL ASSEMBLY RADIAL HEAD AND STEM ELBOW IMPLANT IMPLANTED ON (B)(6) 2011. AFTER IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN, DECREASED FUNCTION AND INSTABILITY OF HIS RIGHT ELBOW. AFTER IMAGES SHOWED LOOSENING OF THE COMPONENTS, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019.
Patient problems: Failure of Implant; Injury; Loss of Range of Motion; Pain
MAUDE report 9960657 ↗
Other PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices
- EVOLVE 496S275Wright Medical Technology, Inc. · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall6 reports
- NA 03.405.000SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall2 reports
- NA 09.405.966SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall2 reports
- NA 09.405.263SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.250SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- EXPLOR 11-210061Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.583SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.570SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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