NA 04.402.008SRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982128058), received between Dec 6, 2017 and Jan 17, 2023 — classified as 15 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

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2023Device Slipped; Device Slipped

  A LEGAL LETTER RECORD RECEIVED, LEGAL RECORD ALLEGED ON UNKNOWN DATE THAT PATIENT WAS REVISED DUE TO THE BINDING AGENT/SURFACE OF THE STEM, IT HAS A PROPENSITY FOR POOR INGROWTH AND OR A PROPENSITY TO LOOSENING POSTOPERATIVELY. THE DEFECT HAD CAUSED THE PATIENT UNDERGO REVISION SURGERY OF HER ELBOW IMPLANT. DOI: (B)(6) 2016; DOR: UNKNOWN; UNKNOWN AFFECTED SIDE OF ELBOW. THIS REPORT IS FOR AN 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Inadequate Osseointegration

  MAUDE report 16185359 ↗
• InjuryNov 17, 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 12828834 ↗
• InjuryJan 13, 2020Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF RIGHT RADIAL HEAD REPLACEMENT DUE TO LOOSENING OF RADIAL STEM. ON AN UNKNOWN DATE, A PATIENT SUSTAINED A FALL ON HIS OUTSTRETCHED RIGHT UPPER EXTREMITY WHILE PAINTING FROM A LADDER AND PRESENTED WITH A SEVERE INJURY TO THE RIGHT UPPER EXTREMITY AS NOTED. GIVEN THE NATURE OF THE INJURY, HE WAS SEEN URGENTLY IN THE EMERGENCY ROOM AND URGENT SURGERY WAS DONE FOR BEST FUNCTIONAL OUTCOME. PREOPERATIVELY, PATIENT HAD SOME NUMBNESS IN THE ULNAR NERVE DISTRIBUTION, WHICH WAS LIKELY TRACTION TYPE INJURY SECONDARY TO TRAUMA. ON (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT ELBOW RADIAL HEAD REPLACEMENT, CORONOID/LCL REPAIR, ORIF OF RADIAL STYLOID FRACTURE, CRPP OF SMALL FINGER/RINGER P1 BASE FRACTURE, PINNING OF MULTIPLE CARPAL BONES/FOURTH TO FIFTH CMC. OVER THE COURSE OF FOUR YEARS, THE PATIENT HAS BEEN DOING WELL WITH OCCASIONAL ELBOW PAIN WITH ACTIVITY, BUT WITH IMPROVEMENTS IN PAIN WHILE GOING WELL WITH OCCASIONAL THERAPY. ON (B)(6) 2019, THE PATIENT VISITED THE CLINIC FOR RIGHT ELBOW PAIN. RIGHT ELBOW CT DONE ON (B)(6). ON (B)(6) 2019, THE PATIENT HAD A FOLLOW-UP CHECK-UP AND REPORTS PAIN RADIATING FROM ELBOW TO THE

  Patient problems: Nerve Damage; No Code Available; Pain

  MAUDE report 9583046 ↗
• 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: Osteolysis; Pain

  MAUDE report 9311835 ↗
• InjurySep 30, 2019Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A RIGHT ULNA REMOVAL OF DEEP IMPLANT AND RIGHT RADIAL HEAD REMOVAL. THE PATIENT SUSTAINED A COMMINUTED PERIARTICULAR ELBOW FRACTURE. HE HAD EVIDENCE OF A METAPHYSEAL ULNAR FRACTURE WITH EXTENSION TO THE ANTERIOR JOINT WITH DISPLACEMENT OF CORONOID FRAGMENT AS WELL AS A MEDIAL PORTION OF THE METAPHYSEAL REGION AND EXTENDING ALSO TO THE JOINT. HE ALSO HAD A COMMINUTED PARTIAL ARTICULAR RADIAL HEAD FRACTURE WITH DISPLACEMENT AND WITH WIDELY DISPLACED ARTICULAR FRAGMENTS INTO THE POSTERIOR PORTION OF THE ELBOW JOINT. HE UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION ON AUGUST 26, 2016 TO FACILITATE RESTORATION OF ANATOMIC ALIGNMENT AND RETURN OF EARLY FUNCTION. REPORTED CONCOMITANT DEVICES: 2 HOLE OLECRANON PLATE (PART# 02.107.202, LOT # UNKNOWN, QUANTIY#1) 2.7MM LOCKING SCREW, 16MM (PART# 02.211.016, LOT # UNKNOWN, QUANTIY#1) 2.7MM LOCKING SCREW, 18MM (PART#02.211.018, LOT # UNKNOWN, QUANTIY#2) 2.7MM LOCKING SCREW, 20MM (02.211.020, LOT # UNKNOWN, QUANTIY#2) 2.7 MM LOCKING SCREW, 24MM (PART# 02.211.024, LOT # UNKNOWN, QUANTIY#1) 2.7MM LOCKING SREW, 26MM (PART# 02.211.026, LOT # UNKNOWN, QUANTIY#1) 2.7MM LOCKING SREW, 28MM (PART# 0

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9136318 ↗
• 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 8423127 ↗
• 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 8267264 ↗
• InjuryJan 22, 2019Device Slipped; Loosening of Implant Not Related to Bone-Ingrowth; Device Slipped; Loosening of Implant Not Related to Bone-Ingrowth

  CONCOMITANT DEVICE: RADIAL HEAD (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1).

  Patient problems: No Code Available; Pain

  MAUDE report 8266363 ↗
• InjuryDec 5, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT REVISION OF RADIAL HEAD REPLACEMENT DUE TO LOOSENING OF THE RADIAL HEAD. A NON-SYNTHES DEVICE WAS USED. THE PREVIOUS INCISION WAS MADE OVER THE OLECRANON. THE SUBCUTANEOUS SCAR TISSUE WAS METICULOUSLY TAKEN DOWN AND THE INTERVAL BETWEEN THE ANCONEUS AND THE EXTENSORS WAS DEVELOPED GIVING RISE TO THE RADIAL HEAD. THERE WAS EXTENSIVE SYNOVITIS. THE RADIAL HEAD WAS OBVIOUSLY LOOSE AND CAME OUT WITHOUT ANY TROUBLE. A GREAT DEAL OF THE INFLAMMATORY TISSUE AND SYNOVITIS WAS TAKEN DOWN. A SKELETAL DYNAMICS SYSTEM 11MM IMPLANT WAS PLACED. THE AREA WAS COPIOUSLY IRRIGATED WITH NORMAL SALINE. THE CAPSULE INTERVAL WAS CLOSED DOWN. THE PATIENT WAS TRANSFERRED TO A GURNEY AND TAKE TO PACU IN STABLE CONDITION. ELBOW X-RAY ON (B)(6) 2017 SHOWED RIGHT RADIAL HEAD PROSTHESIS IN PLACE, APPEARS TO HAVE BEEN REPLACED. INTERVAL REMOVAL OF BLADE PLATE AND SCREW FIXATION OF PROXIMAL RIGHT ULNA. TWO SCREWS AND A SUTURE ANCHOR REMAIN WITHIN THE PROXIMAL RIGHT ULNA. ON (B)(6) 2016, THE PATIENT WAS ADMITTED IN THE ER AND NOTED TO HAVE RIGHT PROXIMAL ULNAR AND RADIAL HEAD FRACTURE DUE TO FALL. THE PATIENT EXPERIENCED DIZZINESS. THE PATIENT CANNOT MOVE

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 8135386 ↗
• InjuryDec 4, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT REMOVAL OF RADIAL HEAD IMPLANT DUE TO LOOSENING WITH LUCENCY IN THE BONE SURROUNDING THE STEM PORTION OF THE RADIAL HEAD. THE SURGEON WAS ABLE TO GRASP THE RADIAL HEAD IMPLANT AND REMOVE IT IN ONE PIECE. THERE WAS NO OBVIOUS INFECTION PRESENT. THERE WAS NOT A SIGNIFICANT AMOUNT OF SOFT TISSUE REACTION WITHIN THE BONE. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2015, THE PATIENT WENT TO THE CLINIC WITH SUSTAINED ELBOW FRACTURE DISLOCATION DUE TO FALL. ELBOW X-RAY SHOWED DISLOCATION OF THE LEFT ELBOW WITH COMMINUTED FRACTURE OF THE RADIAL HEAD. ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH SYNTHES 26MM +0 CHROME COBALT RADIAL HEAD AND 8MM X 28MM STRAIGHT STEM DURING RADIAL HEAD ARTHROPLASTY AND REPAIR OF LATERAL COLLATERAL LIGAMENT USING FLUOROSCOPY DUE TO FRACTURE DISLOCATION OF THE LEFT ELBOW WITH RADIAL HEAD. ON (B)(6) 2015, THE PATIENT STILL HAD A FAIR AMOUNT OF SWELLING IN THE ELBOW. PRONATION AND SUPINATION WERE VERY LIMITED. ON (B)(6) 2015, THE PATIENT HAD SOME MILD SWELLING AROUND THE ELBOW. X-RAY RESULT SHOWED A MINIMAL AMOUNT OF CALCIFICATION. ON (B)(6) 2015,

  Patient problems: Osteolysis; Pain

  MAUDE report 8130614 ↗
• 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 8130567 ↗
• InjuryJul 23, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2016, DUE TO A FALL, WHICH RESULTED IN A FRACTURE OF THE LEFT ELBOW. PATIENT INJURIES INCLUDED A LEFT CORONOID FRACTURE WITH A LEFT RADIAL HEAD FRACTURE. THE PATIENT WAS IMPLANTED WITH ONE (1) 8MM RADIAL STEM, ONE (1) 20MM RADIAL HEAD AND ONE (1) NON-SYNTHES K WIRE GUIDE. ON AN UNKNOWN DATE POST-OPERATIVE, THE PATIENT PRESENTED WITH PAIN AND LIMITED MOBILITY. THE PATIENT WAS PRESCRIBED PHYSICAL THERAPY TO ADDRESS THE PAIN AND MOBILITY ISSUE. IN (B)(6) 2017, THRU X-RAY, IS WAS OBSERVED THAT THE IMPLANT APPEARED LUCENCY, WHICH SUGGESTED TO A LOOSE IMPLANT. ON (B)(6) 2017, THE SURGEON REMOVED THE RADIAL HEAD PROSTHESIS IMPLANTS. IT WAS REPORTED THAT AFTER THE PATIENT HAD THE IMPLANTS REMOVED, ANOTHER ROUND OF PHYSICAL THERAPY WAS PRESCRIBED. CURRENTLY, THE PATIENT IS STILL SUFFERING FROM PAIN AS WELL AS LIMITATIONS IN HER STRENGTH AND MOBILITY. DUE TO THE ADDITIONAL SURGERY TO REMOVE THE DEVICE, THE PATIENT IS PRESENTING WITH HASTENED ARTHRITIS ISSUES IN HER LEFT ELBOW. CONCOMITANT DEVICE: NON-SYNTHES WIRE K WIRE GUIDE 1.1MM X 5.5IN (ITEM: 1600-022, LOT: 0416288163, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Arthritis; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 7711482 ↗
• InjuryJan 2, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A SYNTHES RADIAL HEAD IMPLANT WAS REMOVED ON (B)(6) 2017 AFTER FIXATION WAS NEARING FAILURE DUE TO OSTEOLYSIS AROUND THE STEM AS EVIDENCED BY LUCENCY VISIBLE ON THE PRE-OP X-RAYS. THE RADIAL HEAD AND STEM WERE REMOVED INTACT. THE PATIENT WAS NOT IMPLANTED WITH ANY NEW HARDWARE. NO SURGICAL DELAY. THE IMPLANTS WERE INITIALLY IMPLANTED EARLIER THIS YEAR IN 2017. CONCOMITANT DEVICES REPORTED: 22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE (PART # 09.402.022S, LOT # 7068118, QUANTITY # 1). THIS REPORT IS FOR ONE (1) 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE. (B)(4).

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 7156765 ↗
• InjuryDec 20, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REMOVAL OF RADIAL HEAD PROSTHESIS ON (B)(6) 2017 DUE TO PAIN, BONE DAMAGE AND LOOSENING OF THE RADIAL STEM. THE PATIENT WAS INITIALLY IMPLANTED WITH RADIAL HEAD PROSTHESIS ON (B)(6) 2016 FOR AN UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT AND THEIR SURGEON BECAME AWARE OF THE RADIAL HEAD LOOSENING IN (B)(6) 2017, HOWEVER, SURGEON DECIDED TO WAIT AND LET THE BONE HEAL AS DESCRIBED BY THE PATIENT. RADIOGRAPHIC IMAGES TAKEN (UNAVAILABLE) DURING A FOLLOW-UP VISIT BEFORE THE REMOVAL OF RADIAL HEAD PROSTHESIS WERE DESCRIBED BY THE PATIENT TO SHOW AIR AROUND THE X-RAY. DURING A FOLLOW-UP VISIT IN (B)(6) 2017, THE SURGEON DECIDED TO REMOVE THE RADIAL HEAD AND THE REMOVAL PROCEDURE WAS CONDUCTED ON (B)(6) 2017. CONCOMITANT DEVICES REPORTED: RADIAL HEAD (PART 09.402.024S, LOT H086270, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Injury; Pain

  MAUDE report 7134212 ↗
• InjuryDec 6, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2016 FOR TREATMENT OF A CLOSED PROXIMAL DISPLACED FRACTURE HEAD OF THE LEFT RADIUS. PATIENT WAS IMPLANTED WITH ONE (1) 8MM STRAIGHT RADIAL STEM 28MM AND ONE (1) 24MM RADIAL HEAD 4MM HEIGHT EXTENSION/17.0MM. ON (B)(6) 2017 DURING A POSTOPERATIVE FOLLOW UP VISIT, PATIENT PRESENTED WITH PAIN AND LOOSENING OF HARDWARE. REVISION SURGERY HAS BEEN SCHEDULED FOR SOME TIME IN DECEMBER 2017. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7087510 ↗

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