MILLER
Received Apr 16, 2026 · Event occurred Mar 19, 2026
Report 0001822565-2026-01308 · MDR key 24896149
Device
Generic name
Dispenser, Cement
Manufacturer
Zimmer Biomet, Inc.Catalog number
00506905200
Lot number
66693475
Product problems
- Delivered as Unsterile Product
- Tear, Rip or Hole in Device Packaging
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D9; H2; H3; H6 COMPLAINT IS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED AN OUTER CAVITY CRACK WITH ONE EDGE SPLIT OPEN; THE INNER CAVITY EXHIBITED NO DAMAGE OR BREACH. STERILITY HAS BEEN COMPROMISED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION(S). MEDICAL RECORDS WERE NOT PROVIDED. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO TRANSIT DAMAGE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT THE STERILE PLASTIC TRAY GOT CRACKED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.