NA 04.402.007SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982128041), received between Dec 6, 2018 and May 25, 2023 — classified as 11 injuries.

The most frequently reported specific device problem is “Unintended Movement” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K112030); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2023Device Slipped; Device Slipped

  IT WAS REPORTED: ON OR ABOUT (B)(6) 2015 THE PATIENT SUFFERED A FALL, RESULTING IN A RADIAL HEAD FRACTURE IN HER RIGHT ARM. ON (B)(6) 2015 THE PATIENT UNDERWENT RIGHT RADIAL HEAD ARTHROPLASTY AND THE SURGEON IMPLANTED A DEPUY SYNTHES RADIAL HEAD PROSTHESIS SYSTEM TO PATIENT'S ARM TO REPAIR AND SECURE THE FRACTURE. ON (B)(6) 2021 THE PATIENT'S PHYSICIANS DETERMINED THAT THE DEPUY SYNTHES RADIAL HEAD PROSTHESIS SYSTEM IMPLANTED DURING THE 2015 SURGERY HAD LOOSENED AND WAS OTHERWISE DEFECTIVE. THE PATIENT'S RIGHT ARM FAILED, LOOSENED AND CAUSE DEGRADATION OF THE CORTICAL BONE DUE TO A DEFECT IN THE IMPLANT, LEADING TO PERIPROSTHETIC FRACTURES CHARACTERISTICS OF FAILURES WITH THIS SPECIFIC IMPLANT. THE PATIENT EXPERIENCED PAIN, TENDERNESS AND DISCOMFORT IN HER RIGHT UPPER EXTREMITY. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR (1)7MM TI STRAIGHT RADIAL STEM 26MM-STERILE.

  Patient problems: Discomfort; Pain

  MAUDE report 17001525 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DEVICE WAS EXPLANTED AND WAS FOUND TO BE GROSSLY LOOSE AND HAD DESTRUCTIVE PATTERN OF THE PROXIMAL RADIUS. ON (B)(6) 2016 THE PATIENT FELL, FRACTURING HER LEFT RADIAL HEAD AND HER CORONOID PROCESS. ON (B)(6) 2016 A DEPUY SYNTHES RADIAL HEAD PROSTHESIS WAS IMPLANTED. IN 2021, THE PATIENT DEVELOPED SIGNIFICANT PAIN AND HER PRIMARY CARE PHYSICIAN OBTAINED AN X-RAY ON (B)(6) 2021, THAT SHOWED THE STEM OF THE HARDWARE WAS WITH SURROUNDING LUCENCY OF INDETERMINATE CHRONICITY. THE PATIENT WAS THEN REFERRED TO AN ORTHOPEDIC SURGEON WHO OBTAINED A CT SCAN THAT SHOWED PERIHARDWARE LUCENCY ABOUT THE STEM OF THE ARTHROPLASTY HARDWARE MEASURING UP TO 2-3MM. THERE IS NO HARDWARE FRACTURE. HOWEVER, THERE IS COMPLETE BONE LOSS AT THE POSTERIOR ASPECT OF THE ARTHROPLASTY HARDWARE INVOLVING APPROXIMATELY 50% OF THE LENGTH OF THE STEM. THIS REPORT INVOLVES ONE (1) 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 14715591 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT RADIAL HEAD REVISION RECONSTRUCTION, REMOVAL OF HARDWARE OF THE OLECRANON AS WELL AS THE RADIAL HEAD, LYSIS OF ADHESION AND DEBRIDEMENT AND WAS IMPLANTED WITH A NON-SYNTHES DEVICE DUE TO A RIGHT ELBOW RADIAL HEAD REPLACEMENT FAILURE, SYMPTOMATIC HARDWARE WITH STIFFNESS AND INCREASING PAIN. ON (B)(6) 2015, THE PATIENT HAS PRESENTED DISCOMFORT WITH PAIN OVER THE RIGHT ELBOW WHICH RADIATES TO THE RIGHT ELBOW. THE PATIENT FELL DOWN ON HER ELBOW AND SUSTAINED A FRACTURE DISLOCATION. SHE ALSO HAD NERVE SYMPTOMS MOSTLY IN THE ULNAR DISTRIBUTION. ON (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT OLECRANON OPEN REDUCTION INTERNAL FIXATION, RADIAL HEAD RESECTION WITH RADIAL HEAD REPLACEMENT AND OPEN REDUCTION OF RADIAL HEAD AND WAS IMPLANTED WITH DEPUY SYNTHES 20MM DIAMETER HEAD AND A 4 HOLE LONG RIGHT OLECRANON PLATE. THE PATIENT WAS DIAGNOSED WITH RIGHT ELBOW FRACTURE-DISLOCATION, RADIAL HEAD OLECRANON COMMINUTED FRACTURE AND ULNAR NEURAPRAXIA. ON (B)(6) 2016, CT RIGHT UPPER EXTREMITY SHOWS PLATE AND SCREW FIXATION OF THE PROXIMAL ULNA. COMMINUTED INTRA-ARTICULAR FRACTURE NOW WITH BRIDGING CALLUS FORMATION. BRIDGING CALLUS FORM

  Patient problems: Bone Fracture(s); Muscular Rigidity; Pain

  MAUDE report 11251872 ↗
• InjuryMay 15, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION LEFT RADIAL HEAD ARTHROPLASTY DUE TO LEFT FAILED RADIAL HEAD ARTHROPLASTY. SHE DEVELOPED OSTEOLYSIS OF THE IMPLANT. THE IMPLANT WAS NOTED TO HAVE BEEN RECALLED AFTER ITS PLACEMENT. THERE WAS A NOTE TO BE A MODERATE AMOUNT OF SYNOVITIS WITHIN THE JOINT. THE IMPLANT WAS NOTED TO BE LOOSE AND THE IMPLANT WAS SUBSEQUENTLY REMOVED. ON (B)(6) 2016, THE PATIENT UNDERWENT A CLOSED REDUCTION LEFT FRACTURE-DISLOCATION OF THE ELBOW DUE TO FRACTURE DISLOCATION LEFT ELBOW, RADIAL HEAD FRACTURE W/ LATERAL EPICONDYLE FRACTURE, AND DISLOCATION OF THE ELBOW JOINT. ON (B)(6) 2016, THE PATIENT WHO IS A S/P FRACTURE-DISLOCATION OF HER LEFT ELBOW AND HAD A HIGHLY COMMINUTED RADIAL HEAD FRACTURE UNDERWENT A LEFT ELBOW RADIAL HEAD ARTHROPLASTY WITH LATERAL ULNAR COLLATERAL LIGAMENT REPAIR. ON (B)(6) 2018, THE PATIENT HAD A FOLLOW-UP VISIT AND CLAIMS TO HAVE STIFFNESS ISSUES POSTOPERATIVELY, REPORTS PAIN IN THE LATERAL ELBOW BUT ATTENDS EXTENSIVE THERAPY. CONCOMITANT DEVICES REPORTED: 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-STERILE (PART NUMBER 09.402.020S, LOT H021034, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 7MM TI STRAIGHT RADI

  Patient problems: Failure of Implant; No Code Available; Osteolysis

  MAUDE report 10061307 ↗
• InjuryDec 16, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT ELBOW RADIAL HEAD REPLACEMENT WITH DEPUY SYNTHES RADIAL HEAD PROSTHESIS SYSTEM. ON OR ABOUT (B)(6) 2018, THE PATIENT UNDERWENT A REMOVAL AND REPLACEMENT OF THE RADIAL HEAD SYSTEM DUE TO LOOSENING. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 7 MM TI STRAIGHT RADIAL STEM 26 MM-STERILE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9477138 ↗
• InjuryJul 10, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2016, THE PATIENT SUSTAINED AN INJURY TO THE LEFT ELBOW. HE FELL FROM A HEIGHT LANDING ON THE LEFT ARM WITH IMMEDIATE ONSET OF PAIN, SWELLING, AND INABILITY TO MOBILIZE THE LEFT ELBOW. HE WAS SEEN AT THE EMERGENCY ROOM. EVALUATION WAS PERFORMED AND X-RAYS WERE OBTAINED DOCUMENTING EVIDENCE FOR A COMMINUTED DISPLACED PROXIMAL RADIAL HEAD FRACTURE. SPLINTING PROVIDED AND ORTHOPEDIC FOLLOW-UP WITH THE TRAUMA WAS ARRANGED. HE WAS SEEN THERE, REPEAT X-RAYS WERE OBTAINED, AND ARRANGEMENTS WERE MADE FOR SURGICAL TREATMENT. ON (B)(6) 2018, THE PATIENT PRESENTED TO TRIAGE FOR LEFT UPPER EXTREMITY PAIN AND REDNESS. ON PHYSICAL EXAMINATION SHOWS LEFT ELBOW TENDERNESS, SWELLING AND ERYTHEMA. PATIENT PRESENTED TO EMERGENCY DEPARTMENT FOR PAIN AND SWELLING AND MANAGED FOR PAIN AND RECOMMENDED FOR FOLLOW UP. ON (B)(6) 2018, RADIOGRAPHS WERE DONE, IT WAS NOTED THAT THERE WAS CONSIDERABLE OSTEOLYSIS AROUND THE IMPLANT, WHICH WAS LOOSE AND NONFUNCTIONING. THERE WAS RESORPTION OF BONE AND LOSS OF PROXIMAL RADIUS BONE STRUCTURE. HE WAS PREPARED FOR SURGERY. POSTOPERATIVE COURSE WAS COMPLICATED BY A SUPERFICIAL INFECTION, WHICH RESOLVED. FOLLOW-UP EVALUATIONS DOCUMENTED PERSISTENT LOSS OF ELB

  Patient problems: Erythema; No Code Available; Osteolysis; Pain; Swelling; Unspecified Infection

  MAUDE report 8776976 ↗
• InjuryApr 16, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT HAD A RIGHT ELBOW AND RIGHT FOREARM REMOVAL OF HEADWARE DUE TO CHRONIC RIGHT WRIST PAIN, WITH PAINFUL RETAINED HARDWARE OF THE RIGHT FOREARM AND RIGHT ELBOW. WHICH IS THE IMPLANT WAS NOTED TO BE APPRECIABLY LOOSE. ON (B)(6) 2015, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE MIDSHAFT ULNA AND RADIAL HEAD REPLACEMENT USING A SYNTHES RADIAL HEAD/STEM AFTER THE MOTOR VEHICULAR ACCIDENT (MVA) ON (B)(6) 2015. ON (B)(6) 2018, THE PATIENT EXPERIENCE RIGHT ELBOW PAIN AND SWELLING. THE PATIENT EXPERIENCE LUCENCY AROUND THE IMPLANT AROUND THE STEM OF THE RADIAL HEAD ARTHROPLASTY. ASEPTIC LOOSENING OF THE IMPLANTS IS A KNOWN COMPLICATION OF THE RADIAL HEAD IMPLANTATION AND GIVEN THE COMMINUTED NATURE OF THE TRAUMA IN 2015 RADIAL HEAD ARTHROPLASTY WAS INDICATED. THE X-RAY RESULT ON (B)(6) 2018, THE RIGHT ELBOW MULTIPLE CASSETTES DEMONSTRATE SIGNIFICANT INSTABILITY OF THE RADIAL HEAD SHAFT COMPONENT, WITH SUBSTANTIAL WALLOWING. ON (B)(6) 2018, THE PATIENT STATES THAT THE SWELLING CAME BACK OVER THE WEEKEND AND IT IS GETTING A CATCHING FEELING IN THE ELBOW AND THE WRIST. THE PATIENT DESCRIBES THE PAIN AS FATIGUE. ON (B)(6) 2

  Patient problems: Hypoesthesia; Loss of Range of Motion; Pain

  MAUDE report 8518786 ↗
• InjuryMar 15, 2019Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION SURGERY WITH THE REMOVAL OF RADIAL HEAD PROSTHESIS DUE TO LOOSENING OF THE RADIAL HEAD STEM. INITIALLY, ON (B)(6) 2015, THE PATIENT HAD FRACTURE DISLOCATION OF THE RIGHT ELBOW JOINT WITH A FRACTURE OF CORONOID CAUSED BY A MOTORCYCLE ACCIDENT WHEN HIS MOTORCYCLE CRASHED INTO THE CAR IN FRONT OF HIM AT 40MPH. THE PATIENT RECALLED HIS HEAD HITTING THE REAR OF THE CAR AND HE FELL DOWN. UPON STANDING, THE PATIENT FELT PAIN IN HIS RIGHT ARM. HE EXHIBITED A DECREASED RANGE OF MOTION, SWELLING, AND DEFORMITY. TENDERNESS WAS FOUND. ON (B)(6) 2015, THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF RIGHT DISLOCATED ELBOW AND WAS IMPLANTED WITH A RADIAL HEAD PROSTHESIS SYSTEM ALONG WITH THE REPAIR OF CORONOID AND REPAIR OF THE ANTERIOR CRUCIATE LIGAMENT. ON (B)(6) 2016, PATIENT HAD A FOLLOW-UP X-RAY ON THE RIGHT ELBOW WHICH DEMONSTRATED A RIGHT RADIAL HEAD REPLACEMENT IN ANATOMIC ALIGNMENT. THERE WAS SOME INCREASED LUCENCY ABOUT THE RADIAL STEM COMPATIBLE WITH LOOSENING WHICH HAS INCREASED FROM PREVIOUS. SOME MILD HETEROTROPIC OSSIFICATION WERE SEEN ALONG THE ANTERIOR ASPECT OF THE JOINT AND ALSO ABOUT THE MEDIAL H

  Patient problems: Failure of Implant

  MAUDE report 8426097 ↗
• InjuryMar 14, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REMOVAL OF IMPLANT (DEEP) DUE TO LOOSENING AND PERIPROSTHETIC FRACTURE, AND ANCONEUS RATIONAL MYOPLASTY. A BRACHIAL PLEXUS ON-Q CATHETER WAS ALSO PLACED. AN INCISION WAS MADE OVER THE ANCONEUS. THE FASCIA WAS INCISED OVER THE ANCONEUS, PEDICLED IT OFF THE NEUROVASCULAR PEDICLE AND TOOK IT OFF THE ULNA. THE CAPSULED WAS ALSO INCISED. THE IMPLANT BASICALLY FELL OUT OF THE WOUND AND MULTIPLE CULTURE OF THE SCAR TISSUE WERE TAKEN. THE CAPITELLUM WAS EBURNATED. FLUOROSCOPY WAS PERFORMED BOTH IN VARUS-VALGUS AND AT THE DRUJ WAS STABLE. THE TOP OF ANCONEUS WAS PEDICLE INTO THE JOINT AND THEN THE CAPSULE WAS CLOSED USING 2 MITEK G2 ANCHORS. THE ELBOW WAS STABLE AT THIS POINT. ON (B)(6) 2015, THE PATIENT WHO WAS MOUNTAIN CLIMBING IN AN INDOOR GYM WHEN SHE NOTED IMMEDIATE PAIN AND DISCOMFORT IN THE RIGHT ELBOW AFTER A FALL FROM ABOUT 15 FEET. THE PAIN WAS SEVERE, AND THE PATIENT FELT THAT HER ELBOW WAS OUT OF POSITION. ON (B)(6) 2015, RADIOGRAPHS SHOWED A COMMINUTED FRACTURE OF THE RADIAL HEAD WITH IMPACTION WITH SUBLUXED RADIAL HEAD. A CLOSED REDUCTION OF THE RIGHT ELBOW WAS PERFORMED. ON (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8422061 ↗
• InjuryDec 31, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN OPEN REDUCTION AND INTERNAL FIXATION OF PROXIMAL ULNA, RADIAL HEAD ARTHROPATHY AND LATERAL COLLATERAL LIGAMENT REPAIR FOR LEFT ELBOW FRACTURE AND DISLOCATION ON (B)(6) 2016 AND NOT ON (B)(6) 2016 AS REPORTED ON PREVIOUS MEDWATCH REPORT.

  Patient problems: Osteolysis; Pain

  MAUDE report 8206838 ↗
• InjuryDec 6, 2018Device Slipped; Unintended Movement; Device Slipped; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF LEFT RADIAL HEAD PROSTHESIS. A 2.2 CM CYSTIC AREA OF OSTEOLYSIS WITHIN THE TRUNCATED PROXIMAL RADIUS CORRESPONDS TO AN AREA OF PROSTHESIS LOOSENING ON PRIOR RADIOGRAPHS. THERE IS NO ADJACENT MARROW EDEMA CURRENTLY. SURGICAL OUTCOME AND PATIENT STATUS WERE NOT REPORTED. THIS REPORT IS FOR ONE (1) 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8137374 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112030. One submission often covers many models, so check the product and lot details in each record.

• Z-1124-2017 · Dec 29, 2016 · Terminated
  Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
• Z-1238-2013 · Feb 22, 2013 · Terminated
  Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and