NA 09.402.020SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982132581), received between Jul 3, 2018 and Aug 16, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Slipped” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 8901608 ↗
• 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) 8 MM RADIAL STEM, ONE (1) 20 MM 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 1.1 MM X 5.5 IN (ITEM 1600-022, LOT 0416288163, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 7711539 ↗
• InjuryJul 3, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS REPORTED BY THE FACILITY THAT MEDWATCH (B)(4) HAS BEEN SUBMITTED TO THE FDA ON JUNE 7, 2018. THE REPORTED PATIENT WAS A (B)(6) FEMALE THAT UNDERWENT REMOVAL OF RIGHT RADIUS AND ULNA IMPLANT & HARDWARE ON (B)(6) 2018 DUE TO PROGRESSIVE LOOSENING OF THE IMPLANT AND OSTEOLYSIS AROUND THE OTHER METAL IN HER ELBOW. THE PATIENT COMPLAINED OF CLICKING AND DISCOMFORT. THE ORIGINAL IMPLANT DATE (B)(6) 2015. EXPLANTED (B)(6) 2018. INTRA-OPERATIVE, THE INTRAOSSEOUS CYSTIC LESION IN THE OLECRANON WAS FILLED WITH DEMINERALIZED BONE MATRIX. THE RADIAL HEAD SYSTEM AND HARDWARE HAD BEEN IMPLANTED ON (B)(6) 2015, FOR RIGHT ELBOW FRACTURE-DISLOCATION REQUIRING REDIAL HEAD ARTHROPLASTY. FOLLOWING AN UNEVENTFUL, COURSE, THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2018. AS OF (B)(6) 2018, POST-OPERATIVE OFFICE VISIT: NO ACUTE DISTRESS. INCISION SITES CLEAN DRY AND INTACT. WITHOUT EVIDENCE OF INFECTION. SUTURES REMOVED. PASSIVE RANGE OF MOTION THROUGH RIGHT ELBOW 10 DEGREES IN EXTENSION TO 110 DEGREES OF FLEXION, SUPINATION 30-DEGREE, PRONATION 60 DEGRE

  Patient problems: Discomfort; Osteolysis

  MAUDE report 7659821 ↗

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