NA 09.402.026SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982132611), received between Dec 18, 2018 and Jan 13, 2020 — 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.

• 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 9582955 ↗
• InjuryJul 10, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2016, THE PATIENT SUSTAINED AN INJURY TO THE LEFT ELBOW. HE FELL FROM A HEIGHT LANDING ON THE LEFT ARM WITH IMMEDIATE ONSET OF PAIN, SWELLING, AND INABILITY TO MOBILIZE THE LEFT ELBOW. HE WAS SEEN AT THE EMERGENCY ROOM. EVALUATION WAS PERFORMED AND X-RAYS WERE OBTAINED DOCUMENTING EVIDENCE FOR A COMMINUTED DISPLACED PROXIMAL RADIAL HEAD FRACTURE. SPLINTING PROVIDED AND ORTHOPEDIC FOLLOW-UP WITH THE TRAUMA WAS ARRANGED. HE WAS SEEN THERE, REPEAT X-RAYS WERE OBTAINED, AND ARRANGEMENTS WERE MADE FOR SURGICAL TREATMENT. ON (B)(6) 2018, THE PATIENT PRESENTED TO TRIAGE FOR LEFT UPPER EXTREMITY PAIN AND REDNESS. ON PHYSICAL EXAMINATION SHOWS LEFT ELBOW TENDERNESS, SWELLING AND ERYTHEMA. PATIENT PRESENTED TO EMERGENCY DEPARTMENT FOR PAIN AND SWELLING AND MANAGED FOR PAIN AND RECOMMENDED FOR FOLLOW UP. ON (B)(6) 2018, RADIOGRAPHS WERE DONE, IT WAS NOTED THAT THERE WAS CONSIDERABLE OSTEOLYSIS AROUND THE IMPLANT, WHICH WAS LOOSE AND NONFUNCTIONING. THERE WAS RESORPTION OF BONE AND LOSS OF PROXIMAL RADIUS BONE STRUCTURE. HE WAS PREPARED FOR SURGERY. POSTOPERATIVE COURSE WAS COMPLICATED BY A SUPERFICIAL INFECTION, WHICH RESOLVED. FOLLOW-UP EVALUATIONS DOCUMENTED PERSISTENT LOSS OF ELB

  Patient problems: Erythema; No Code Available; Osteolysis; Pain; Swelling; Unspecified Infection

  MAUDE report 8777035 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REMOVAL SURGERY. THE PATIENT REQUIRED AN ADDITIONAL SURGERY TO REMOVE THE COBALT CHROMIUM RADIAL HEAD STANDARD HEIGHT DUE TO OSTEOLYSIS FOLLOWING THE IMPLANTATION OF RADIAL HEAD REPLACEMENT. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 8177569 ↗

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