UNKNOWN EXPLOR IMPLANT STEM W/SCREW
Received Aug 6, 2025 · Event occurred Dec 6, 2024
Report 0001825034-2025-02387 · MDR key 22729939
Device
Generic name
Elbow Prosthesis/extremities
Manufacturer
Zimmer Biomet, Inc.Catalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Detachment of Device or Device Component
- Adverse Event Without Identified Device or Use Problem
- Detachment of Device or Device Component
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
(B)(4). D10: MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN EXPLOR HEAD; LOT#: UNKNOWN. G2: FOREIGN: BELGIUM H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. H6: COMPONENT CODES: MECHANICAL (G04) - STEM THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY APPROXIMATELY TWO (2) YEARS AND FOUR (4) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY EIGHT (8) MONTHS AGO DUE TO AN UNKNOWN REASON. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.
Additional Manufacturer Narrative
(B)(4). THE FOLLOWING SECTIONS WERE UPDATED: B1; B4; B5; D2; E1; G2; G3; G6; H1; H2; H6. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY APPROXIMATELY TWO (2) EARS AND FIVE (5) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY NINE (9) MONTHS AGO DUE TO THE IMPLANTS DISASSEMBLING.