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NA 09.402.022SRecalls & reported problems

Synthes (U.S.A.) LP · 22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
13
Deaths reported
0
Injuries reported
13
Recalls naming it
0

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982132598), received between Apr 25, 2018 and Jan 29, 2021 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Slipped” (6 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 18, 2026.

Most reported problems

Device problems

  • Device Slipped6
  • Adverse Event Without Identified Device or Use Problem4
  • Unintended Movement2
  • Loosening of Implant Not Related to Bone-Ingrowth1
  • Mechanical Problem1

Patient problems

  • No Code Available9
  • Pain8
  • Bone Fracture(s)2
  • Osteolysis2
  • Failure of Implant1
  • Muscle/Tendon Damage1
  • Muscular Rigidity1
  • Swelling1

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

  • 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 11251716 ↗
  • InjuryDec 10, 2020Device Slipped; Device Slipped

    IT WAS REPORTED THAT ON OR ABOUT MAY 16, 2017, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE SINCE THE SYSTEM FAILED AND CAUSED PAIN AND SEVERE INJURY TO THE PATIENT. ON OR ABOUT DECEMBER 17, 2015, THE PATIENT UNDERWENT SURGICAL PLACEMENT OF A SYNTHES RADIAL HEAD PROSTHESIS SYSTEM ON HER ELBOW FOLLOWING AN INJURY. ON OR ABOUT DECEMBER 2016, SYNTHES ANNOUNCED A RECALL OF THE SYSTEM DUE TO THE DISCOVERY THAT THE SYSTEM WAS DEFECTIVE AND COULD CAUSE THE RADIAL STEM TO LOOSEN POST-OPERATIVELY AT THE STEM BONE INTERFACE. THIS REPORT IS FOR ONE (1) UNK - RADIAL HEAD PROSTHESIS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: Muscle/Tendon Damage; Pain

    MAUDE report 10985227 ↗
  • InjuryNov 17, 2020Device Slipped; Unintended Movement; Device Slipped; Unintended Movement

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN IMPLANT REMOVAL LEFT ELBOW AND DEBRIDEMENT IN THE LEFT ELBOW. THE SURGEON REMOVED THE RADIAL HEAD PROSTHESIS BUT DID NOT IMPLANT ANOTHER DEVICE ON OR ABOUT (B)(6) 2016, THE PATIENT TRIPPED AND FELL, RESULTING IN A FRACTURE OF HER LEFT RADIAL HEAD. ON OR ABOUT (B)(6) 2016, THE PATIENT UNDERWENT A COMMINUTED AND MARKEDLY DISPLACED FRACTURE OF THE RADIAL BONE BUT NO OTHER INJURIES AND WAS IMPLANTED WITH A SYNTHES RADIAL HEAD AND STEM. AFTER SURGERY, PATIENT THEN BEGAN EXPERIENCING PAIN IN HER LEFT ARM, MAINLY IN THE FOREARM AREA WHERE THE RADIAL HEAD STEAM WAS LOCATED. ON (B)(6) 2019, THE PATIENT TRIPPED OVER A CURB AND FELL AND LANDED ON HER HANDS AND KNEES AND SUFFERED A PERIPROSTHETIC FRACTURE OF THE RADIAL NECK. THE RADIAL IMPLANT HAS BECOME LOOSENED. ON THE (B)(6) 2019 SHE VISITED THE SURGEON BECAUSE SHE WAS EXPERIENCING PAIN AND PAIN WAS 5/10 AND SHE HAD BEEN TAKING TYLENOL AND IBUPROFEN FOR THE PAIN. X-RAYS TAKEN AND SHOWED A ¿PERIPROSTHETIC FRACTURE OF THE PROXIMAL RADIAL DIAPHYSIS WITH PERIPROSTHETIC LUCENCY.¿ SURGEON EXPLAINED THAT THE RADIAL HEAD PROSTHESIS WAS LOOSE, WHICH CAUSED THE BONE TO HOLLOW OUT OVER TIME

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

    MAUDE report 10852521 ↗
  • InjuryNov 12, 2019Device Slipped; Device Slipped

    IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION OF HIS RIGHT RADIAL HEAD. ON (B)(6) 2016, A PATIENT FELL ABOUT SIX FEET OFF A LADDER AND SUSTAINED BILATERAL ELBOW FRACTURE DISLOCATIONS OF BOTH ELBOWS. CLOSED REDUCTION OF FRACTURE DISLOCATIONS ON THE SAME DAY IN THE EMERGENCY DEPARTMENT WAS PERFORMED. ON (B)(6) 2016, THE PATIENT UNDERWENT LEFT ELBOW FRACTURE DISLOCATION RADIAL HEAD REPLACEMENT, AND LATERAL COLLATERAL LIGAMENT REPAIR AND LONG ARM CAST. RIGHT ELBOW FRACTURE DISLOCATION LONG ARM CAST BY REPLACING IT WITH A SYNTHES RADIAL HEAD PROSTHESIS. ON (B)(6) 2016, THE PATIENT UNDERWENT CLOSED REDUCTION OF RIGHT ELBOW FRACTURE-DISLOCATION WITH A SPLINTING DUE TO RIGHT ELBOW FRACTURE DISLOCATION. ON (B)(6) 2018, THE PATIENT WAS INFORMED BY THE SURGEON THAT HIS IMPLANT IS FAILING. X-RAYS SHOWED LOOSENING OF THE RADIAL HEAD PROSTHESIS WITH PRESUMED SIGNIFICANT OSTEOLYSIS AROUND THE RADIAL HEAD IMPLANT. MORE LIKELY THAN NOT THE DEPUY SYNTHES RADIAL HEAD AND STEM WILL REQUIRE SURGICAL REMOVAL FROM THE PATIENT'S LEFT ARM AND POSSIBLY ADDITIONAL FUTURE "SALVAGE" SURGERIES. DUE TO A FAILED AND DEFECTIVE RADIAL HEAD PROSTHESIS SYSTEM, THE PATIENT

    Patient problems: No Code Available; Osteolysis; Pain

    MAUDE report 9311856 ↗
  • InjuryOct 28, 2019Device Slipped; Device Slipped

    IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2016, THE PATIENT HAS SUFFERED FROM A COMMINUTED RIGHT RADIAL HEAD FRACTURE WITH DISPLACED FRAGMENTS FROM A MOTOR VEHICLE COLLISION INJURING HER RIGHT ELBOW, INCLUDING A THREE-PART FRACTURE OF THE RIGHT RADIAL HEAD. ON AN UNKNOWN DATE IN (B)(6) 2016, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION AND HEAD ARTHROPLASTY SURGERY TO REPAIR THE FRACTURE OF HER RIGHT RADIAL HEAD. A SYNTHES RADIAL HEAD AND STEM WERE IMPLANTED. ON AN UNKNOWN DATE, IN LATE 2016, THE PATIENT BEGAN SUFFERING FROM PAIN IN HER RIGHT ARM AND WAS CONCERNED THAT HER ELBOW WAS NOT RECOVERING. THROUGHOUT 2017 AND EARLY 2018, THE PATIENT CONTINUED TO HAVE PAIN, FUNCTION, AND MOBILITY ISSUES. A BONE SCAN WAS DONE IN (B)(6) 2018 BUT FAILED TO REVEAL ANY PROBLEMS WITH THE RADIAL HEAD PROSTHESIS. IN (B)(6) 2019, THE PATIENT'S RIGHT ELBOW LOCKED UP AND SOUGHT TREATMENT IN THE ER. IN (B)(6) 2019, IMAGING SHOWED SIGNS OF LOOSENING OF THE RADIAL HEAD AND WAS RECOMMENDED FOR REMOVAL SURGERY. ON AN UNKNOWN DATE ON (B)(6) 2019, THE PATIENT UNDERWENT SURGERY TO REMOVE THE LOOSE RADIAL HEAD PROSTHESIS. IT WAS ALSO NOTED THAT THERE WAS A RADIAL HEAD ARTHROPLASTY WITH NO

    Patient problems: No Code Available; Pain

    MAUDE report 9247943 ↗
  • InjuryMay 28, 2019Device Slipped; Device Slipped

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF COBALT CHROMIUM RADIAL HEAD STANDARD HEIGHT-STERILE & TITANIUM STRAIGHT RADIAL STEM-STERILE, DUE TO LOOSENING OF RADIAL PROSTHESIS STEM. THE HARDWARE WAS REMOVED UNEVENTFULLY, AND THE PATIENT UNDERWENT A RADIAL HEAD RESECTION AND ADVANCEMENT OF THE LATERAL LIGAMENT. PATIENT WAS ORIGINALLY TREATED WITH RADIAL HEAD PROSTHESIS FOR RADIAL HEAD FRACTURE ON (B)(6) 2013. PROCEDURE OUTCOME WAS UNKNOWN. THE PATIENT EXPERIENCED PAIN AND ELBOW INSTABILITY. THIS REPORT IS FOR ONE (1) RADIAL HEAD. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Code Available; Pain

    MAUDE report 8645455 ↗
  • InjuryJan 30, 2019Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL SURGERY DUE TO A LOOSENING OF THE RADIAL HEAD PROSTHESIS THAT WAS IMPLANTED SEVERAL YEARS AGO. THE IMPLANTS WERE REMOVED WITH NO ADVERSE EVENTS. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Code Available

    MAUDE report 8289888 ↗
  • InjuryJan 22, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT REVISION TO REMOVE THE RADIAL HEAD PROSTHESIS SYSTEM DUE TO INCREASED PAIN CAUSED BY LOOSENING OF THE IMPLANT WITH EXTENSIVE SURROUNDING OSTEOLYSIS. SURGEON¿S OPERATIVE REPORT STATED THAT THE RADIAL HEAD IMPLANT AND STEM WERE NOTED TO BE LOOSE WITH EXTENSIVE SURROUNDING OSTEOLYSIS THAT THE RADIAL HEAD COULD SPIN WITHIN THE CANAL AND WAS ALSO PISTONING PROXIMAL AND DISTAL WITHIN THE PROXIMAL PORTION AS WELL. THE RADIAL HEAD IMPLANT WAS THEN EASILY REMOVED, OWING TO THE OSTEOLYSIS. IT WAS ALSO NOTED THAT SECONDARY TO THE OSTEOLYSIS THERE HAD BEEN AN ADDITIONAL BONE LOSS COMPARED TO THE INITIAL RESECTION. THERE WERE ALSO 2 UNKNOWN SYNTHES HEADLESS COMPRESSION SCREWS, WHICH HAD PREVIOUSLY BEEN BURIED WELL BELOW THE CARTILAGE AND WERE NOW SLIGHTLY VISIBLE, THAT WERE ELECTIVELY REMOVED FROM CAPITELLUM OR OSTEOCHONDRAL GRAFT. ON (B)(6) 2016, THE PATIENT FELL OUTSIDE OF HER HOME INJURING HER LEFT ELBOW INCLUDING A FRACTURE OF THE LEFT RADIAL HEAD. SHE SUFFERED FROM A TERRIBLE TRIAD INJURY. ON (B)(6) 2016, THE PATIENT UNDERWENT SURGERY TO REPAIR THE FRACTURE OF HER LEFT RADIAL HEAD AND WAS IMPLANTED WITH A SYNTHES 22MM RADIAL HEAD S

    Patient problems: No Code Available; Osteolysis

    MAUDE report 8269120 ↗
  • InjuryJan 18, 2019Device Slipped; Device Slipped

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL PROCEDURE OF THE RIGHT RADIAL HEAD REPLACEMENT DUE TO PROSTHETIC LOOSENING. ON (B)(6) 2015, THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE RIGHT RADIAL HEAD PROSTHESIS DUE TO PAIN AND LOOSENING AND ANTERIOR TRANSPOSITION OF ULNAR NERVE RIGHT ELBOW AND WAS IMPLANTED WITH A TITANIUM CURVED RADIAL STEM 44MM STERILE AND COBALT CHROMIUM RADIAL HEAD STANDARD HEIGHT 12.5MM STERILE. ON (B)(6) 2015, THE PATIENT COMPLAINED OF CONTINUED PAIN AND POPPING IN THE RIGHT ELBOW, AS WELL AS IN THE RIGHT WRIST. THE SYMPTOMS WERE WORSE WITH FOREARM ROTATION. THE PAIN IN THE ELBOW RADIATES INTO THE FOREARM AND DOWN TO THE WRIST. THE PATIENT WAS ALSO BOTHERED BY THE PLATE WHICH WAS PROMINENT OVER THE RIGHT ELBOW. ON (B)(6) 2015, THE PATIENT UNDERWENT A REMOVAL PROCEDURE OF PAINFUL HARDWARE PROXIMAL ASPECT OF RIGHT ULNA. ON AUGUST 13, 2015, X-RAY REVEALED A SLIGHT LUCENCY SEEN AROUND THE STEM OF THE COMPONENT AND WITH INTERVAL REMOVAL OF OLECRANON PLATE. ON (B)(6) 2018, X-RAY RESULT REVEALED LOOSENING AROUND THE STEM. ON (B)(6) 2019, DURING A CLINIC VISIT, THE PATIENT REPORTED INCREASING PAIN SINCE THE TIME OF THE RADIAL HEAD REVISIO

    Patient problems: Failure of Implant

    MAUDE report 8261884 ↗
  • InjuryOct 10, 2018Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF RIGHT RADIAL HEAD PROSTHESIS SYSTEM ON (B)(6) 2017. PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION ON (B)(6) 2016 AND WAS IMPLANTED WITH RADIAL HEAD PROSTHESIS SYSTEM DUE TO BROKEN RIGHT ELBOW THAT HAPPENED IN AN ADULT RELAY TYPE RACE IN WHICH PATIENT WAS ON A SET OF MONKEY BARS AND FELL TO THE GROUND. ON (B)(6) 2016 PRE-OPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN TAKEN AND REVEALED SEVERELY COMMINUTED, INTRA-ARTICULAR FRACTURE HEAD AND NECK WITH A LARGE JOINT EFFUSION. INITIAL SURGERY WAS SUCCESSFUL, PATIENT WAS IN STABLE CONDITION WITH NO COMPLICATIONS. ON (B)(6) 2017 BONE SCAN REVEALED LUCENCY AROUND THE STEM OF THE RADIAL HEAD PROSTHESIS. ON (B)(6) 2017, DURING THE FOLLOW UP VISIT, PATIENT HAD NOT PROGRESS IN MOTION AND HAVING A LOT OF PAIN. ON AN UNKNOWN DATE, PATIENT HAD A POSTOPERATIVE X-RAYS THAT SHOWED OSTEOLYSIS AROUND THE STEM OF THE RADIAL HEAD PROSTHESIS AND THE RADIAL HEAD PROSTHESIS WAS PISTONING IN THE BONE BASED ON THE X-RAYS. DURING REVISION PROCEDURE, THE TISSUE AROUND THE JOINT WAS NOTED TO VERY HYPERTROPHIC. THE RADIAL HEAD IMPLANT WAS NOTED TO BE VERY LOOSE AND WAS SPINNING FREELY AROUND THE BONE AND HA

    Patient problems: No Code Available

    MAUDE report 7952173 ↗
  • 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: No Code Available; Pain; Swelling

    MAUDE report 7895669 ↗
  • 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 ABLATION WAS USED TO FINISH THE DEBRIDEMENT. AFTER STITCHING THE PORTALS WITH A SIMPLE MONOCRYL STITCH, POST-OPERATIVE ANALGESIA WAS PROVIDED. BEFORE DRESS

    Patient problems: No Code Available

    MAUDE report 7716619 ↗
  • InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED PATIENT WAS IMPLANTED WITH THE RADIAL HEAD PROSTHESIS SYSTEM ON UNKNOWN DATE. ON AN UNKNOWN DATE PATIENT REPORTED PAIN. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON INTENDED TO REMOVE BOTH THE RADIAL HEAD AND RADIAL STEM. HOWEVER, ONLY THE RADIAL HEAD WAS ABLE TO BE REMOVED. THE RADIAL STEM COULD NOT BE REMOVED DUE TO BONY GROWTH. SURGERY WAS COMPLETED WITH NO REPORTED DELAY. PATIENT REPORTED TO BE IN STABLE CONDITION. THERE IS CURRENTLY NO PLAN TO ATTEMPT TO REMOVE THE RADIAL STEM. THIS REPORT IS FOR ONE (1) 22MM RADIAL HEAD STANDARD HEIGHT 12.5MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: Pain

    MAUDE report 7463200 ↗

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

Other PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices

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Sources and updates

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