RHEAD 310-0009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886385022765), received between Sep 27, 2018 and Jun 7, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryJun 7, 2019Device Slipped

  IT WAS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE CLAIMANT HAD A LEFT STRYKER LATERAL RADIAL HEAD AND STEM ELBOW IMPLANT SYSTEM IMPLANTED ON (B)(6) 2017. IT IS FURTHER ALLEGED THAT FOLLOWING HER REPLACEMENT SURGERY, PATIENT PRESENTED BACK TO SURGEON WITH COMPLAINTS OF INCREASING PAIN AND DECREASED FUNCTION OF HER ELBOW. AFTER IMAGING SHOWED LOOSENING OF THE COMPONENTS, SURGEON RECOMMENDED PATIENT UNDERGO A REVISION SURGERY, WHICH TOOK PLACE ON (B)(6) 2017. DURING THE REVISION SURGERY, SURGEON DESCRIBED THE LOCKING MECHANISM AS LOOSE AND THE RADIAL HEAD "UNCOUPLED FROM THE STEM."

  Patient problems: Pain

  MAUDE report 8680920 ↗
• InjurySep 27, 2018Loose or Intermittent Connection; Device Dislodged or Dislocated

  A SURGEON CUSTOMER COMPLAINED THAT A RADIAL HEAD IMPLANT DID NOT WORK PROPERLY. UPDATE 26-SEPT-2018: "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 OF PRIMARY.

  Patient problems: Pain

  MAUDE report 7914647 ↗