UNK BROACH
Received Mar 31, 2026 · Event occurred Jul 30, 2021
Report 0001825034-2026-00786 · MDR key 24740253
Device
Product problems
- Patient Device Interaction Problem
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) ¿ RASP. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT HAD AN INITIAL RIGHT THA. DURING THE PROCEDURE THE FEMUR WAS BROACHED TO AN 18, TRIAL REDUCTION WAS DONE HIP WAS STABLE BUT APPEARED SLIGHTLY LONG CLINICALLY. SIZE 18 STEM WAS USED WITH A TYPE 1 TAPER AND STABLE PRESS FIT. THE STEM SAT 2-3 MM PROUD COMPARED TO WHERE THE BROACH WAS. FINAL IMPLANTS PLACED WITH NO INTRAOPERATIVE COMPLICATIONS. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE HIP PROCEDURE, THE STEM DID NOT FULLY SEAT. IT WAS POSSIBLY 2 TO 3 MM PROUD COMPARED TO THE BROACH WAS. THE STEM WAS LEFT IN PLACE AND PROCEDURE COMPLETED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.