NA 04.402.027SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982128096), received between Dec 29, 2017 and Sep 30, 2019 — classified as 11 injuries.

The most frequently reported specific device problem is “Unintended Movement” (5 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.

• InjurySep 30, 2019Device Slipped; Unintended Movement; Device Slipped; Unintended Movement

  NO IMPLANTS SHOWN IN THE IMAGES RECEIVED.

  Patient problems: No Code Available; Pain

  MAUDE report 9134819 ↗
• InjuryAug 16, 2019Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT REMOVAL OF A FAILED RADIAL HEAD IMPLANT DUE TO SEVERE PAIN AND THE LOOSENING OF THE IMPLANT. THE COCR RADIAL HEAD AND TITANIUM RADIAL STEM WERE REMOVED. PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT STATUS IS STABLE. THE PATIENT INJURED THEIR LEFT ELBOW ON (B)(6) 2014 AND WENT TO THE HOSPITAL ON (B)(6) 2019 WHERE X-RAYS WERE TAKEN. ON (B)(6) 2014, THE PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION WITH THE COCR RADIAL HEAD AND TITANIUM RADIAL STEM. X-RAYS OF THE PATIENT¿S LEFT ELBOW TAKEN ON (B)(6) 2014, SHOWED GOOD ALIGNMENT OF THE RADIAL HEAD REPLACEMENT. THE CORONOID FRACTURE LOOKED LIKE IT WAS HEALING NICELY. X-RAYS TAKEN ON (B)(6) 2014, SHOWED CONTINUING GOOD ALIGNMENT OF THE RADIAL HEAD REPLACEMENT. THE FRACTURE WAS WELL REDUCED. PATIENT WAS ADVISED THEY COULD WEAN OF THEIR BRACE. ON (B)(6) 2014, THE PATIENT COMPLAINED OF PAIN. IT WAS ALSO NOTED THAT THE FRACTURE WAS HEALED. PATIENT WAS STILL EXPERIENCING SORENESS ON (B)(6) 2014. ON (B)(6) 2017, THE PATIENT COMPLAINED OF INCREASED PAIN IN THE LEFT ELBOW OVER THE LAST TWO (2) MONTHS OR SO. THE PATIENT¿S LEFT ELBOW HAS SOME TENDERNESS LATERALLY. THREE VIEWS OF THE PATIENTS

  Patient problems: No Code Available; Pain

  MAUDE report 8901687 ↗
• InjuryJan 10, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION WITH WRIGHT MEDIAL RADIAL HEAD IMPLANT. REMOVAL WAS DUE TO A LOOSE IMPLANT. BONE LOSS AROUND THE STEM WAS ALSO REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) 7MM TI CURVED RADIAL STEM 42MM-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 8237199 ↗
• InjuryDec 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT REMOVAL OF RADIAL HEAD IMPLANT, REVISION OF HEAD ARTHROPLASTY WITH LATERAL COLLATERAL LIGAMENT REPAIR AND ELBOW SYNOVECTOMY DUE TO IMPLANT LOOSENING. THE TIMELINE OF EVENTS IS FOLLOWING: ON (B)(6) 2016, PATIENT WENT TO THE ER DEPARTMENT WITH COMPLAINTS OF LEFT ARM PAIN. X-RAYS WERE TAKEN, AND SPLINT WAS APPLIED. A FRACTURE WAS IDENTIFIED UPON ELBOW X-RAY. ON (B)(6) 2016, THE PATIENT UNDERWENT PROSTHETIC REPLACEMENT OF LEFT RADIAL USING UNKNOWN SYNTHES PROSTHETIC RADIAL HEAD WITH A LONG PRESSFIT STEM SIZE 7 AND A SIZE 22 +0 HEAD DUE TO LEFT RADIAL HEAD FRACTURE. FROM (B)(6) 2017 TO (B)(6) 2017, THE PATIENT RETURNED TO THE CLINIC WITH COMPLAINTS OF CHRONIC PAIN IN THE LEFT WRIST AND LEFT UPPER SHOULDER PAIN. THE PATIENT FELT PAIN IN THE DISTAL FOREARM AND DISTAL RADIOULNAR JOINT (DRUJ). THE PAIN GOT WORST WITH ACTIVITY AND BETTER WITH REST. THE PATIENT FELT SOME VAGUE NUMBNESS AND TINGLING IN THE ARM. THE PATIENT TRIED A BRACE, HEAR, ICE, OVER THE COUNTER CREAMS AND NON-STEROIDAL ANTI-INFLAMMATORIES BUT WITHOUT SUFFICIENT RELIEF. DRUJ INJECTION ALSO DID NOT PROVIDE RELIEF. ELBOW X-RAY, 5 VIEWS WAS TAKEN ON (B)(6) 2017 AND DEM

  Patient problems: Hypoesthesia; No Code Available; Pain

  MAUDE report 8135710 ↗
• InjuryDec 4, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT REMOVAL OF RADIAL HEAD IMPLANT, OPEN REDUCTION INTERNAL FIXATION (ORIF) OF PERIPROSTHETIC LEFT PROXIMAL RADIUS FRACTURE NONUNION, AND BONE GRAFTING OF LEFT PROXIMAL RADIUS FRACTURE WITH ALLOGRAFT DUE TO A LOOSE LEFT RADIAL HEAD IMPLANT WITH PERIPROSTHETIC PROXIMAL RADIUS FRACTURE. THE RADIAL HEAD IMPLANT WAS IDENTIFIED AND NOTED TO BE VERY LOOSE. THE COUPLING SCREW BETWEEN THE HEAD AND THE STEM WAS REMOVED AND THE HEAD WAS EXPLANTED. THE STEM WAS THEN EASILY EXPLANTED AS WELL. A PARTIALLY THREADED SYNTHES 6.5MM CANNULATED SCREW WITH A SYNTHES WASHER WAS THEN USED AND PLACED OVER THE GUIDEWIRE. THERE WERE NO SIGNS OF INFECTIONS. THERE WAS EXCELLENT COMPRESSION OF THE FRACTURE SITE WITH APPROPRIATE CANNULATED SCREW PLACEMENT AND LENGTH. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH 22MM RADIAL HEAD PROSTHESIS ON (B)(6) 2016, DURING RADIAL HEAD ARTHROPLASTY DUE TO RADIAL NECK FRACTURE MALUNION. ON (B)(6) 2017, THE PATIENT WENT TO THE CLINIC FOR A POSTOPERATIVE VISIT AND STATED THAT THE SYMPTOMS WORSENED COMPARED TO THE PREOPERATIVE SYMPTOMS. THE PATIENT HAD SHOWN A DECREASE IN ACTIVITY LEVEL. INCISION WAS WELL HEALED WITHOUT SIGN

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8129617 ↗
• InjurySep 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A US BURSA ASPIRATION AND ATTEMPT JOINT ASPIRATION PROCEDURE ON (B)(6) 2017 DUE TO RIGHT ELBOW PAIN AND SWELLING. THE PATIENT INITIALLY SUFFERED A RADIAL HEAD FRACTURE WHEN HE FELL ABOUT FIFTEEN (15) FEET FROM A LADDER ON (B)(6) 2016. PATIENT STATED THAT THEY ¿RODE A LADDER¿ WHEN THE FOOT OF THE LADDER LOST TRACTION, CAUSING THE LADDER TO SLIDE DOWN THE SIDE OF THE HOUSE. SUBSEQUENTLY, THE PATIENT PRESENTED TO THE HOSPITAL THE NEXT DAY, AND UPON FOLLOW-UP ON (B)(6) 2016, A COMPUTER TOMOGRAPHY (CT) SCAN AND MULTIPLE X-RAY IMAGES OF THE RIGHT ELBOW CONFIRMED A RADIAL HEAD FRACTURE. THE PATIENT WAS ALSO DIAGNOSED WITH AN AVULSION FRACTURE OF THE LEFT ANKLE, ADJACENT TO THE TALUS, CONTUSION, ABRASIONS AND TARSAL FRACTURE. PATIENT PRESENTED WITH SYMPTOMS OF PAIN, SWELLING AND BRUISING AFTER THE FALL. FOLLOWING THIS, THE PATIENT WAS INITIALLY IMPLANTED WITH A RADIAL HEAD AND STEM CONSTRUCT ON (B)(6) 2016 TO TREAT A RADIAL HEAD FRACTURE. THE SURGEON, DURING A FOLLOW-UP VISIT ON AN UNKNOWN DATE NOTICED SOME SPACE BETWEEN THE HARDWARE AND THE BONE. GRADUALLY, THE PATIENT DEVELOPED INCREASED PAIN, DECREASED RANGE OF MOTION, SWELLING AND INABILITY TO U

  Patient problems: Pain; Swelling

  MAUDE report 7895634 ↗
• InjuryJul 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROSCOPY OF THE RIGHT WRIST WITH TFCC DEBRIDEMENT AND MANIPULATION OF RIGHT ELBOW UNDER ANESTHESIA ON (B)(6) 2017 AS THEY HAD DEVELOPED A POSTOP ELBOW CONTRACTURE AND HAD SUSTAINED A CENTRAL POST-TRAUMATIC TFCC TEAR TO THE RIGHT WRIST ON AN UNKNOWN DATE. THE PATIENT WAS INITIALLY IMPLANTED WITH A RADIAL HEAD AND STEM CONSTRUCT ON (B)(6) 2016 TO TREAT A RADIAL HEAD FRACTURE. AS PER THE PATIENT¿S ACCOUNT, THE SHAFT (RADIAL STEM) WAS NOT RETAINING TO THE BONE AND WAS CAUSING MORE DAMAGE TO THE BONE THAN HELP SUPPORT IT. AFTER THE INITIAL IMPLANT OF RADIAL HEAD PROSTHESIS ON (B)(6) 2016, THE PATIENT DEVELOPED A POSTOP CONTRACTURE AND HAD SUSTAINED A CENTRAL POST-TRAUMATIC TFCC TEAR TO THE RIGHT WRIST ON AN UNKNOWN DATE. ON (B)(6) 2017, THE PATIENT UNDERWENT AN ARTHROSCOPY OF THE RIGHT WRIST WITH TFCC DEBRIDEMENT AND MANIPULATION OF RIGHT ELBOW UNDER ANESTHESIA. AFTER DEBRIDING THE LARGE DEGENERATIVE CENTRAL TEAR WHICH WAS ELLIPTICAL IN NATURE ALONG THE TFCC MENISCAL DISC, RADIOFREQUENCY ABLATOR WAS USED TO FINISH THE DEBRIDEMENT. AFTER STITCHING THE PORTALS WITH A SIMPLE MONOCRYL STITCH, POST-OPERATIVE ANALGESIA WAS PROVIDED. BEFORE DRESSI

  Patient problems: No Code Available

  MAUDE report 7716617 ↗
• InjuryMar 29, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A HARDWARE REMOVAL PROCEDURE TOOK PLACE ON (B)(6) 2018 DUE TO THE LOOSENING OF A RADIAL HEAD PROSTHESIS STEM IMPLANT. THE PATIENT CAME TO THE EMERGENCY ROOM ON AN UNKNOWN DATE WITH UNKNOWN COMPLAINTS. IT WAS DURING THAT VISIT THAT AN X-RAY WAS TAKEN AND IT WAS DISCOVERED THAT THE RADIAL HEAD PROSTHESIS STEM WAS LOOSE. BOTH PARTS OF THE TWO-PIECE IMPLANT WERE REMOVED DURING THE (B)(6) PROCEDURE. THE X-RAY TAKEN IN THE EMERGENCY ROOM IS NOT AVAILABLE. THE HARDWARE REMOVAL PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS. THE PATIENT WAS NOT REVISED TO ANYTHING BECAUSE HER FRACTURE WAS STABLE. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE PROCEDURE. NO INFORMATION IS AVAILABLE ABOUT THE ORIGINAL IMPLANT PROCEDURE OF THE DEVICE. THIS REPORT INVOLVES 1 DEVICES. REPORTED CONCOMITANT DEVICE 22MM COCR RADIAL HEAD (PART NUMBER: 09.402.622S, LOT NUMBER: 7607102, QUANTITY: 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7384221 ↗
• InjuryMar 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REMOVAL OF A RADIAL HEAD AND STEM PROSTHESIS ON (B)(6) 2018. THE REMOVAL WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THE PATIENT WAS NOT REVISED TO ANYTHING FOLLOWING THE PROCEDURE. IT IS UNKNOWN WHY THE DEVICES WERE REMOVED. THE SALES CONSULTANT BELIEVES IT MAY HAVE BEEN DUE TO A PATIENTS COMPLAINT OF PAINS. THIS REPORT INVOLVES 2 DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7379569 ↗
• 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) 7MM TI CURVED RADIAL STEM 42MM-STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 7245453 ↗
• InjuryDec 29, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REMOVAL OF A RADIAL HEAD PROSTHESIS ON (B)(6)2017 DUE TO SEVERE PAIN AND LOSING FUNCTIONALITY AND MOBILITY IN THE ARM FOR ABOUT ONE MONTH BEFORE THE REVISION. THE PATIENT HAD FALLEN ON AN UNKNOWN DATE AND SUSTAINED MULTIPLE INJURIES/FRACTURES. FOLLOWING THIS, THE PATIENT WAS INITIALLY IMPLANTED WITH A RADIAL HEAD AND STEM CONSTRUCT ON (B)(6) 2016 TO TREAT A RADIAL HEAD FRACTURE. AS PER THE PATIENT¿S ACCOUNT, THE SHAFT (RADIAL STEM) WAS NOT RETAINING TO THE BONE AND WAS CAUSING MORE DAMAGE TO THE BONE THAN HELP SUPPORT IT. THE SURGEON, DURING A FOLLOW-UP VISIT ON AN UNKNOWN DATE NOTICED SOME SPACE BETWEEN THE HARDWARE AND THE BONE. GRADUALLY, THE PATIENT DEVELOPED INCREASED PAIN, DECREASED RANGE OF MOTION, SWELLING AND INABILITY TO USE THE RIGHT ARM FOR ANY ACTIVITIES DESPITE AGGRESSIVE PHYSICAL THERAPY. THE PATIENT IS RIGHT HANDED. UNKNOWN NUMBER OF X-RAYS WERE TAKEN AT AN UNKNOWN TIME SHOWED THINNING OF BONE AROUND THE RADIAL HEAD IMPLANT. AFTER THE INITIAL IMPLANT OF RADIAL HEAD PROSTHESIS ON (B)(6) 2016, THE PATIENT DEVELOPED A POSTOP CONTRACTURE AND HAD SUSTAINED A CENTRAL POST-TRAUMATIC TFCC TEAR TO THE RIGHT WRIST ON AN UNKNOWN DATE.

  Patient problems: No Code Available; Pain

  MAUDE report 7155551 ↗

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