UNKNOWN SCREW
Received Aug 1, 2025
Report 0001825034-2025-02337 · MDR key 22687263
Device
Generic name
Elbow Implan/extremities
Manufacturer
Zimmer Biomet, Inc.Catalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Corroded
- Corroded
Patient
NA · Unknown
- Metal Related Pathology
- Metal Related Pathology
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY APPROXIMATELY FOUR (4) YEARS AGO. SUBSEQUENTLY, THE PATIENT THE PATIENT UNDERWENT A REVISION SURGERY ON AN UNKNOWN DATE DUE TO SOFT TISSUE METALLOSIS AND DESTRUCTION OF THE CAPITULUM HUMERI SURFACE.
Additional Manufacturer Narrative
(B)(4). D10: MEDICAL PRODUCTS: ITEM#: 11-210063, EXPLOR 8X28MM IMPL STEM W/SCR; LOT#: 680440. ITEM#: 11-210041, EXPLOR 10X24 MM IMPLANT HEAD; LOT#: 382560. G2: FOREIGN: POLAND. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL/CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2. UPON RECEIVING ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED ON. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. 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
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.