BIOMET EBI BONE HEALING SYSTEM
Received Aug 1, 2025
Report 0002242816-2025-00093 · MDR key 22685691
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
82 YR · Female
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO HIGHRIDGE MEDICAL FOR EVALUATION; THEREFORE NO PRODUCT EVALUATION HAS BEEN CONDUCTED. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR TRENDS. AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS (B)(6) OF 2025.
Description of Event or Problem
IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED PAIN IN THE KNEE WHILE USING THE BHS ASSEMBLY. THE PATIENT DID NOT INDICATE THE PAIN LEVEL.
Description of Event or Problem
IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED PAIN IN THE KNEE WHILE USING THE BHS ASSEMBLY. THE PATIENT DID NOT INDICATE THE PAIN LEVEL.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION IN THE FOLLOWING FIELDS, B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER. H2: FOLLOW UP TYPE, H6: EVALUATION CODES. CORRECTED DATA IN THE FOLLOWING FIELDS, H6: DEVICE CODE. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE DEVICE WAS NOT RETURNED TO EBI FOR EVALUATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED AS THE LOT NUMBER OF THE PRODUCT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. RELATED MANUFACTURERS REPORTS: 0002242816-2025-00092.