UNKNOWN EVOLVE STEM
Received Jun 26, 2025 · Event occurred Jun 6, 2025
Report 3010667733-2025-00770 · MDR key 22335698
Device
Generic name
Prosthesis, Elbow, Semi-constrained, Cemented
Manufacturer
Wright Medical Technology IncCatalog number
UNK_WWA
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Extraskeletal ossification
- Loss of Range of Motion
- Extraskeletal ossification
- Loss of Range of Motion
Narrative
Description of Event or Problem
THE MANUFACTURER RECEIVED A STRYKER COLLABORATIVE STUDY NAMED "PROSPECTIVE DATA COLLECTION OF THE TREATMENT FOR TOTAL REPLACEMENT OF THE RADIAL HEAD WITH THE EVOLVE PROLINE IMPLANT" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF EVOLVEPROLINE. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN (B)(6) 2010 TO (B)(6) 2021. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: FOR 4 PATIENTS HETEROTROPIC OSSIFICATION. THIS IS PATIENT 4 OUT OF 4.
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 MANUFACTURER RECEIVED A STRYKER COLLABORATIVE STUDY NAMED "PROSPECTIVE DATA COLLECTION OF THE TREATMENT FOR TOTAL REPLACEMENT OF THE RADIAL HEAD WITH THE EVOLVE PROLINE IMPLANT" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF EVOLVEPROLINE. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN JANUARY 2010 TO JULY 2021. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: FOR 4 PATIENTS HETEROTROPIC OSSIFICATION. THIS IS PATIENT 4 OUT OF 4.
Additional Manufacturer Narrative
CORRECTION - PLEASE REFER H6 HEALTH IMPACT CODE. 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.