NA 09.402.218SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982132635), received between Jan 29, 2021 and Jan 29, 2021 — classified as 1 injury.

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 1 most recent of 1 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 11252447 ↗

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