RHEAD RHA-H4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886385024684), received between May 8, 2018 and Oct 1, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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. How this data works · Data updated Oct 13, 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 1, 2018Loosening of Implant Not Related to Bone-Ingrowth

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(6) ARTHROPLASTY REGISTER ((B)(6)). THE TITLE OF THIS REPORT IS ¿RHEAD REPORTED IN THE (B)(6) ARTHROPLASTY REGISTER ((B)(6))¿ WHICH IS ASSOCIATED WITH THE RHEAD SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 2002 AND 2017. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 3 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO LOOSENING OF THE DISTAL COMPONENT IN 2007.

  Patient problems: No Code Available

  MAUDE report 7923918 ↗
• InjuryMay 8, 2018Failure To Adhere Or Bond

  PATIENT CALLED AND STATED THAT HE HAD A ELBOW REPLACEMENT DONE ON (B)(6) 2017. ON OR ABOUT (B)(6) 2018 HE STARTED EXPERIENCING PAIN IN HIS ELBOW. HE WENT TO HIS DOCTOR AND HAD X-RAYS AND WAS TOLD THAT THE IMPLANT HAD LOOSENED AND NEEDS TO BE REPLACED. PATIENT IS ALSO INQUIRING ABOUT RECALL.

  Patient problems: Pain

  MAUDE report 7493790 ↗