EXPLOR 9X30MM IMPL STEM W/SCR
Received Apr 4, 2025 · Event occurred Nov 16, 2017
Report 0001825034-2025-00993 · MDR key 21772977
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
(B)(4). PROPOSED CODE: MECHANICAL (G04)- STEM. D10: CAT: 11-210032, LOT: 868560, EXPLOR 12X22MM IMPLANT HEAD. G2: FOREIGN- EU: NORWAY. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE WRIST APPROXIMATELY TWO MONTHS POST IMPLANTATION. THE PATIENT UNDERWENT ULNA SHORTENING OSTEOTOMY PROCEDURE AS A TREATMENT FOR PAIN. NO FURTHER INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; D5; G1; G3; G6; H1; H2; H3; H6; H10. THE REPORTED EVENT IS NOT CONFIRMED. PRODUCT HAS NOT BEEN EVALUATED AS IT HAS BEEN DETERMINED THE EVENT IS NOT RELATED TO DEVICE. ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.