UNKNOWN EVOLVE RADIAL HEAD
Received Jun 26, 2025 · Event occurred Jun 6, 2025
Report 3010667733-2025-00763 · MDR key 22334380
Device
Generic name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Manufacturer
Wright Medical Technology IncCatalog number
UNK_WWA
Lot number
UNKNOWN
Product problems
- Osseointegration Problem
- Osseointegration Problem
Patient
NA · Unknown
- Inadequate Osseointegration
- Inadequate Osseointegration
Narrative
Additional Manufacturer Narrative
THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.
Description of Event or Problem
THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.
Description of Event or Problem
THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.
Additional Manufacturer Narrative
CORRECTION - PLEASE REFER H6 METHOD CODE GRID. THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING LITERATURE AND CLINICAL REVIEW PROCESS. THE ALLEGED EVENT COULD NOT BE CONFIRMED, SINCE NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR OR THE ARTICLE. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, AND MEDICAL REPORTS MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.