MalfunctionJDI
BIO-MOORE ENDO II HIP SYSTEM
Received Jul 17, 2026 · Event occurred Jun 28, 2026
Report 0001825034-2026-02116 · MDR key 25856635
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Manufacturer
Zimmer Biomet, Inc.Catalog number
139246
Lot number
66142280
Product problems
- Device Damaged Prior to Receipt by User
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 THERE WAS AN ISSUE WITH THE STERILE PACKAGING HAVING THERMAL DAMAGE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.