UNK BROACH
Received May 21, 2026 · Event occurred Dec 10, 2025
Report 0001825034-2026-01439 · MDR key 25245014
Device
Product problems
- Patient Device Interaction Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY, THE STEM DID NOT SINK FAR ENOUGH INTO THE FEMUR. THE STEM WAS NOT USED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. G2: FOREIGN - EVENT OCCURRED IN NETHERLANDS. H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) - RASP. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE STEM WAS RETURNED WITH THE ASSOCIATED CERAMIC HEAD ASSEMBLED ON THE TAPER. DUE TO THE ASSEMBLED STATE OF THE STEM AND HEAD THERE IS NO ETCH CONTENT VISIBLE TO VERIFY ON THE STEM. THE STEM HAS MINOR SCRATCHES PRESENT ON THE NECK. THERE ARE MULTIPLE AREAS OF THE POROUS COATING THAT HAVE FOREIGN DEBRIS PRESENT. NO OTHER DAMAGE WAS NOTED DURING VISUAL EVALUATION. MEASUREMENTS WITHIN SPECIFICATION. UNKNOWN BROACH NOT RETURNED FOR REVIEW. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT IS NOT CONFIRMED. 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.