BI POLAR RADIAL CUP 22MM DIA
Received Oct 15, 2024 · Event occurred Sep 15, 2023
Report 3000931034-2024-00619 · MDR key 20451843
Device
Generic name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Manufacturer
Tornier S.a.s.Catalog number
DTJ022
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
49 YR · Male
- Extraskeletal ossification
- Implant Pain
- Extraskeletal ossification
- Implant Pain
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
AS REPORTED: "WELBOW STUDY SUBJECT (B)(6): ONE MONTH AFTER THE SURGERY INVOLVING THE CRF II IMPLANT, HETEROTOPIC OSSIFICATION WITH NEUROPATHIC PAIN WAS OBSERVED. IT WAS OBSERVED A NEUROPATHIC PAIN STARTING FROM THE ELBOW AND RADIATING THROUGH THE RIGHT UPPER LIMB. TO ADDRESS THIS ISSUE REHABILITATION AND PHYSICAL THERAPY WERE REQUIRED."