DELTA PF CUP
Received Jun 11, 2026 · Event occurred May 26, 2026
Report 3008021110-2026-00251 · MDR key 25469771
Device
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO PRE-EXISTING ANOMALIES WERE DETECTED BY THE CHECK OF THE DEVICE HISTORY RECORDS OF THE LOT NUMBER INVOLVED. THIS IS THE FIRST AND ONLY COMPLAINT RECORDED ON THIS LOT N. A FINAL REPORT WILL BE SUBMITTED AFTER THE INVESTIGATION.
Description of Event or Problem
INTRA-OPERATIVE ISSUE OCCURRED DURING HIP SURGERY ON (B)(6) 2026: TWO OF THE MAGNETS OF THE DELTA CUP - WRENCH (PRODUCT CODE 9055.51.015, LOT 25AR079) CAME LOOSE WHEN THE DELTA CUP WAS DRIVEN INTO THE ACETABULUM. THE COMPLAINT SOURCE REPORTED THAT THE DELTA CUP WAS STILL ABLE TO BE IMPLANTED AND THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME. THIS EVENT OCCURRED IN GERMANY.