RHEAD 310-0008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886385022758), received between May 25, 2018 and Oct 24, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2018Loose or Intermittent Connection; Device Dislodged or Dislocated

  IT¿S ALLEGED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE PATIENT HAD A STRYKER LATERAL HEAD AND STEM ELBOW IMPLANTED ON OR ABOUT (B)(6) 2016. IT IS FURTHER ALLEGED THAT AFTER HIS ELBOW REPLACEMENT, HE BEGAN TO EXPERIENCE INCREASING PAIN AND DECREASED FUNCTION. HE THEN VISITED HIS ORTHOPEDIC DOCTOR WHO CONFIRMED LOOSENING OF THE RADIAL HEAD COMPONENTS AND RECOMMENDED IMMEDIATE REVISION SURGERY, WHICH TOOK PLACE ON OR ABOUT (B)(6) 2016. WITHIN ONE WEEK OF HIS REVISION SURGERY, THE CLAIMANT HAD TO UNDERGO RE-REVISION OF THE RADIAL HEAD COMPONENT ON OR ABOUT (B)(6) 2016 DUE TO THE COMPONENT COMING LOOSE AND DISLODGING FOR A SECOND TIME. THIS PI IS FOR REVISION 1.

  Patient problems: Pain

  MAUDE report 8002757 ↗
• InjuryMay 25, 2018Detachment Of Device Component

  IT WAS REPORTED THAT PATIENT'S RADIUS WAS REVISED DUE TO THE HEAD DISASSOCIATING FROM THE STEM.

  Patient problems: Failure of Implant

  MAUDE report 7546118 ↗