RHEAD 310-0003Recalls & reported problems
Stryker GmbH · Lateral Assembly, Radial Stem Implant, Size 4 · Class 2 · Implant
All models of RHEAD (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886385022703), received between May 25, 2018 and Jun 7, 2019 — classified as 3 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 18, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Device Dislodged or Dislocated1
- Device Slipped1
Patient problems
- Failure of Implant1
- No Code Available1
- Pain1
Recent adverse event reports
The 3 most recent of 3 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 8680921 ↗InjuryDec 13, 2018Device Dislodged or Dislocated
PATIENT WAS LIFTING A BOX OVERHEAD, LATERAL RADIAL HEAD DISLODGED FROM STEM. BOTH HEAD AND STEM IMPLANTS WERE EXPLANTED. COMPETITIVE PRODUCT USED AS REPLACEMENT.
Patient problems: No Code Available
MAUDE report 8162197 ↗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 7546116 ↗
Other PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED devices
- TEMA Elbow 1590.15.010Limacorporate SPA · Prosthesis, Elbow, Semi-Constrained, Cemented2 recalls3 reports
- TEMA Elbow 1590.15.020Limacorporate SPA · Prosthesis, Elbow, Semi-Constrained, Cemented1 recall1 report
- Latitude™ - Elbow DKY068Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED20 reports
- DURALOC 1241-46-526Depuy Orthopaedics, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED17 reports
- Latitude™ - Elbow DKY067Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED8 reports
- RHS - RADIAL PROSTHESIS DTJ302Tornier · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED6 reports
- Latitude™ EV 0030221Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 reports
- CRF II - RADIAL PROSTHESIS DTJ022Tornier · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 reports
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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