RHEADRecalls & reported problems across all models
Stryker GmbH · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 0
We found 12 models of RHEAD by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Sep 9, 2015 and Aug 8, 2021 — classified as 21 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported RHEAD problems
Device problems
- Device Dislodged or Dislocated6
- Loose or Intermittent Connection5
- Adverse Event Without Identified Device or Use Problem3
- Detachment Of Device Component2
- Device Slipped2
- Failure To Adhere Or Bond2
- Loosening of Implant Not Related to Bone-Ingrowth2
- Loss of Osseointegration2
Patient problems
- Pain13
- Failure of Implant4
- Loss of Range of Motion4
- No Code Available4
- Injury2
- No Known Impact Or Consequence To Patient2
- Unspecified Infection1
RHEAD models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RHEAD 310-0003PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED3 reports
- RHEAD RHA-S2PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER3 reports
- RHEAD 310-0000PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED2 reports
- RHEAD 310-0008PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER2 reports
- RHEAD 310-0009PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER2 reports
- RHEAD RHA-H4PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER2 reports
- RHEAD RCN-S3PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER2 reports
- RHEAD 310-0010PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 report
- RHEAD 310-2011PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 report
- RHEAD RHA-H2PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 report
- RHEAD RHA-H3PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 report
- RHEAD RCN-S160PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 report
Recent RHEAD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT REPORTED THAT FIVE MONTHS POST LEFT RADIAL HEAD ARTHROPLASTY FOR COMMINUTED RADIAL HEAD FRACTURE THEY DEVELOPED INCREASING PAIN AND LOSS RANGE OF MOTION. SURGEONS FOUND PATIENT HAD A GROSSLY RADIAL HEAD IMPLANT WHEN WEIGHT BEARING OF THE RENAL STEM. PATIENT HAD CLOSE TO ZERO PRONATION AND SUPINATION AND LACKING 20 DEGREES EXTENSION. X-RAYS AND REVISION SURGERY CONCLUDED THESE FINDINGS. A SECOND REVISION WAS NEEDED 10 MONTHS AFTER INITIAL SURGERY. THE FIRST REVISION IS CAPTURED ON MFR REPORT # 0008031020-2021-00328.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 12292206 ↗InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT REPORTED THAT FIVE MONTHS POST LEFT RADIAL HEAD ARTHROPLASTY FOR COMMINUTED RADIAL HEAD FRACTURE THEY DEVELOPED INCREASING PAIN AND LOSS RANGE OF MOTION. SURGEONS FOUND PATIENT HAD A GROSSLY RADIAL HEAD IMPLANT WHEN WEIGHT BEARING OF THE RENAL STEM. PATIENT HAD CLOSE TO ZERO PRONATION AND SUPINATION AND LACKING 20 DEGREES EXTENSION. X-RAYS AND REVISION SURGERY CONCLUDED THESE FINDINGS. REVISION SURGERY WAS NEEDED 5 MONTHS AFTER INITIAL SURGERY.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 12249540 ↗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 ↗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 ↗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 ↗InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem
DUE TO THE ALERT SENT OUT BY MHRA DOCTOR REVIEW THE PATIENT WHO HAD AN RHEAD IMPLANTED TWO YEARS AGO THE PATIENT IN QUESTION HAD PRIMARY SURGERY FOR A FRACTURE, HAS NOT BEEN REVISED, HER ACTIVITY LEVEL IS MEDIUM. THERE IS BONE RESORPTION AROUND THE HEAD OF THE RADIAL HEAD IMPLANT BUT NOT AROUND THE IMPLANT STEM.
Patient problems: No Code Available
MAUDE report 8457269 ↗InjuryMar 21, 2019Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN OF THE LEFT RADIUS AFTER IMPLANTATION IN JANUARY 2017. A CT SCAN ON (B)(6)2019 SHOWED LOOSENING OF THE RADIAL HEAD. POSSIBLE CAUSE OR CONTRIBUTOR FOR LOOSENING WAS NOT REPORTED TO THE REP. SURGEON HAS NOT YET REPORTED ANY PLAN TO REVISE THE PATIENT. PER THE OPERATIVE REPORT, AS PART OF THE CT SCAN, SOFT TISSUES APPEARED WITHIN NORMAL LIMITS AND THE REMAINING BONY STRUCTURES WERE UNREMARKABLE, THEREFORE NO SERIOUS INJURY OCCURRED.
Patient problems: Pain
MAUDE report 8441696 ↗InjuryMar 21, 2019Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN OF THE LEFT RADIUS AFTER IMPLANTATION IN (B)(6) 2017. A CT SCAN ON (B)(6), 2019 SHOWED LOOSENING OF THE RADIAL HEAD. POSSIBLE CAUSE OR CONTRIBUTOR FOR LOOSENING WAS NOT REPORTED TO THE REP. SURGEON HAS NOT YET REPORTED ANY PLAN TO REVISE THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8441694 ↗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 Known Impact Or Consequence To Patient
MAUDE report 8162202 ↗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 ↗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: No Code Available; Pain
MAUDE report 8002759 ↗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 ↗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 ↗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 ↗
Other Stryker GmbH products
All Stryker GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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