UNK RADIAL STEM
Received Feb 12, 2025
Report 0001822565-2025-00335 · MDR key 21364013
Device
Product problems
- Corroded
- Corroded
Patient
NA · Unknown
- Metal Related Pathology
- Metal Related Pathology
Narrative
Additional Manufacturer Narrative
(B)(4). G2: POLAND. H3: THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION OR NOT. ONCE THIS INFORMATION IS OBTAINED A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, ON AN UNKNOWN DATE THE PATIENT HAD A REVISION DUE TO SOFT TISSUE METALLOSIS. IT WAS NECESSARY TO REMOVE THE ENTIRE PROSTHESIS DUE TO SOFT TISSUE METALLOSIS AND DESTRUCTION OF THE CAPITULUM HUMERI SURFACE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Additional Manufacturer Narrative
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 1825034.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.