EXPLOR 12X24 MM IMPLANT HEAD

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A PROSTHESIS. SUBSEQUENTLY, THE PATIENT SUFFERED A FRACTURE AND THE IMPLANT BECAME LOOSE. THERE WAS HARM TO THE PATIENT AS THE PATIENT HAD TO UNDERGO ADDITIONAL SURGICAL/MEDICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2, COUNTRY EVENT OCCURRED IN: POLAND. COMPONENT CODES: PROPOSED G-CODE: MECHANICAL (G04) - STEM. D10 NARRATIVE: ITEM: 11-210062, LOT: 66363849, ITEM NAME: EXPLOR 7X26MM IMPL STEM W/SCR. COMPONENT CODES: PROPOSED G-CODE: MECHANICAL (G04) - HEAD. THE PRODUCT IS IN THE PROCESS OF BEING EVALUATED BY ZIMMER BIOMET. ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4, B5, G1, G3, G6, H2, H11. THE FOLLOWING SECTIONS HAVE BEEN CORRECTED: H6, H11. G2, COUNTRY EVENT OCCURRED IN: POLAND. COMPONENT CODES: PROPOSED G-CODE: MECHANICAL (G04) - HEAD. D10 NARRATIVE: ITEM: 11-210062, LOT: 66363849, ITEM NAME: EXPLOR 7X26MM IMPL STEM W/SCR. THE PRODUCT IS IN THE PROCESS OF BEING EVALUATED BY ZIMMER BIOMET. ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

Description of Event or Problem

UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

Additional Manufacturer Narrative

UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.