NA 09.402.024SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982132604), received between Feb 6, 2018 and Nov 16, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SUSTAINED A WORK-RELATED INJURY IN 2016 AND UNDERWENT RADIAL HEAD ARTHROPLASTY WITH A PRESS-FIT RADIAL HEAD IMPLANT. PATIENT HAD DEVELOPED SIGNIFICANT OSTEOLYSIS AND LOOSENING OF HER IMPLANT. REMOVED THE STEM AND WHICH WAS LOOSE WITHIN THE PROXIMAL RADIUS CANAL.

  Patient problems: Pain

  MAUDE report 12822782 ↗
• InjuryApr 15, 2020Adverse 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 REVISION OF LEFT RADIAL HEAD REPLACEMENT DUE TO LEFT RADIAL HEAD REPLACEMENT WITH COMPLICATION. ON AN UNKNOWN DATE, THE PATIENT FELL OFF A LOADING DOCK RESULTING IN A RIGHT LATERAL CONDYLE DISTAL FEMORAL FRACTURE AND LEFT RADIAL HEAD FRACTURE. ON (B)(6) 2016, THE PATIENT UNDERWENT A LEFT RADIAL HEAD REPLACEMENT/ARTHROPLASTY, DUE TO THE LEFT COMMINUTED RADIAL HEAD FRACTURE AND RIGHT ORIF OF DISTAL FEMUR LATERAL CONDYLE FRACTURE, DUE TO RIGHT LATERAL CONDYLE DISTAL FEMORAL FRACTURE. ON (B)(6) 2019, THE PATIENT PRESENTED A LEFT ELBOW PAIN. THE X-RAYS SHOWED THE LEFT ELBOW LUCENCY AROUND THE STEM OF THE RADIAL HEAD IMPLANT AND NO JOINT SPACE BETWEEN HARDWARE ARTICULATION. ON (B)(6) 2019 THE PATIENT IS STILL HAVING PAIN AND WEAKNESS IN THE ELBOW AND OVER TIME IT HAS PROGRESSIVELY WORSENED. THE PATIENT REPORTS TO THE CLINIC ABOUT FOUR WEEKS OUT FROM A POST-REVISION LEFT RADIAL HEAD REPLACEMENT. CONCOMITANT DEVICES REPORTED: 10MM TI STRAIGHT RADIAL STEM 32MM-STERILE (PART NUMBER 04.402.010S, LOT 7012270, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(

  Patient problems: Hypoesthesia; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 9964395 ↗
• InjuryApr 15, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REMOVAL OF THE LEFT ELBOW DUE TO PAINFUL RETAINED HARDWARE INVOLVING THE RADIAL HEAD REPLACEMENT FROM SYNTHES. ON (B)(6) 2014, THE PATIENT HAD A LEFT RADIAL HEAD FRACTURE AND UNDERWENT A REPLACEMENT OF THE LEFT RADIAL HEAD UTILIZING THE SYNTHES SIZE 24 STANDARD HEAD AND A SIZE 9 MM STRAIGHT STEM. ON (B)(6) 2018, THE PATIENT HAD AN AP LATERAL OBLIQUE VIEWS OF THE LEFT ELBOW WHICH SHOWED A LOOSE RADIAL HEAD IMPLANT. CONCOMITANT DEVICES REPORTED: 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE (PART NUMBER 04.402.009S, LOT 7012246, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9962300 ↗
• 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) 24 MM COCR RADIAL HEAD STANDARD HEIGHT/13.0 MM-STERILE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9477133 ↗
• InjuryMar 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION SURGERY OF THE RADIAL HEAD ARTHROPLASTY DUE TO LOOSENING WHICH CAUSED OSTEOLYSIS SURROUNDING THE RADIAL HEAD IMPLANT, AND WAS IMPLANTED WITH A MONOBLOCK IMPLANT, MADE BY ACUMED. THE PATIENT¿S PRIOR SURGICAL INCISION WAS INCISED, AND FULL-THICKNESS FLAPS WERE DEVELOPED AT THE LEVEL OF THE MUSCULAR FASCIA, AN INCISION WAS MADE ALONG THE MID-LATERAL LINE OF THE JOINT UTILIZING THE PRIOR SURGICAL INTERVAL. A CAREFUL AND A LIMITED RELEASE OF THE EXTENSOR MUSCULAR INSERTION THROUGH THE LATERAL EPICONDYLE AND SUPRACONDYLAR RIDGE WAS PERFORMED IN A MANNER TO PERMIT SUBSEQUENT REPAIR. THE JOINT CAPSULE WAS IDENTIFIED AND INCISED. THE PATIENT¿S ANNULAR LIGAMENT WAS DIVIDED. THE UNDERLYING IMPLANT WAS THEN VISUALIZED. CAREFUL SOFT TISSUE DISSECTION WAS PERFORMED MORE DISTALLY, IDENTIFYING THE POSTERIOR INTEROSSEOUS NERVE, WHICH WAS THEN CAREFULLY DISSECTED FREE FROM THE SURROUNDING SOFT TISSUE. AT THIS POINT, THE RADIAL HEAD WAS REMOVED FROM THE STEM, WHICH FOUND TO BE GROSSLY LOOSE WITHIN THE INTRAMEDULLARY CANAL. THE IMPLANT WAS THEN REMOVED, EVALUATED AND FOUND THAT THERE WAS A SIGNIFICANT CORTICAL THINNING AND REMODELIN

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8423123 ↗
• InjuryDec 4, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION OF RADIAL HEAD ARTHROPLASTY USING A NON-SYNTHES DEVICE DUE TO LOOSENING OF THE STEM. A LATERAL INCISION WAS MADE DOWN THROUGH THE PREVIOUSLY-MADE INCISION AND EXTENDED JUST SLIGHTLY PROXIMAL. BLUNT DISSECTION WAS TAKEN DOWN THROUGH THE SUBCUTANEOUS TISSUES, ELEVATING WIDE SKIN FLAPS OVER THE EXTENSOR MUSCULATURE FASCIA. THE EDC MUSCLE WAS SPLIT, AND THE SUPINATOR MUSCLE WAS THEN SEEN. THE CAPSULE AND ANNULAR LIGAMENT WERE OPENED AND THEN THE SYNTHES IMPLANT WAS EASILY SEEN. SHARP DISSECTION WAS TAKEN DISTALLY DOWN TO THE LEVEL OF THE EXISTING RADIAL NECK WITH BLUNT DISSECTION TAKEN DOWN TO THE SUPINATOR MUSCLE, EXCISING THE SUPINATOR FASCIA PROXIMALLY AND THEN SPLITTING THE MUSCLE DISTALLY IN ORDER TO ENSURE THAT THERE WAS NO INJURY TO THE POSTERIOR INTEROSSEOUS NERVE, WHICH WAS NOT ENCOUNTERED. THE SURGEON EASILY REMOVED THE SET SCREW IN THE SYNTHES ARTHROPLASTY AND REMOVED THE HEAD AND THE STEM. THE FINAL IMPLANT WAS THEN OPENED AND IMPACTED INTO PLACE. THE WOUND WAS THEN IRRIGATED GENTLY AND INSERTED THE NECK AND HEAD COMBO INTO THE RADIAL NECK. THE PATIENT WAS THEN TAKEN TO THE RECOVERY ROOM IN STABLE CONDITI

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 8130698 ↗
• InjuryFeb 6, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING SYMPTOMS OF ADVANCING OSTEOLYSIS (BONE DEGENERATION AROUND THE IMPLANT) AFTER A RADIAL HEAD PROSTHESIS IMPLANT ON (B)(6) 2016. AN X-RAY TAKEN ON AN UNKNOWN DATE SHOWS THE STEM OF THE IMPLANT APPEARS TO BE LOOSENING. A REVISION SURGERY HAS NOT YET BEEN SCHEDULED. THIS REPORT IS FOR ONE (1) 24 MM COCR RADIAL HEAD STANDARD HEIGHT/13.0 MM-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 7245450 ↗

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