Conformity Stem 9110-3002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04711605587570), received between May 17, 2024 and Jul 18, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2024Material Disintegration; Structural Problem; Scratched Material; No Apparent Adverse Event; Material Disintegration; Structural Problem; Scratched Material; No Apparent Adverse Event

  THE CALCAR PLANER INSTRUMENT (PART NUMBER 9110-3002) AND BROACH #4 (PART NUMBER 9110-6004-RA) WERE USED DURING A HIP SURGERY ON (B)(6) 2024 AT (B)(6) BY THE SURGEON. THE SURGEON COMPLAINED THAT THE CALCAR PLANNER'S AND BROACH#4 WERE NOT CONNECTING AS INTENDED. SURGEON THEN USED A SMALLER SIZE CALCAR PLANNER TO CONNECT TO THE BROACH AND COMPLETED THE CASE. METAL SHAVING DEBRIS DID NOT COME OUT OF THE INSTRUMENT, HOWEVER, WHEN VISUALLY LOOKING INSIDE THE CALCAR PLANNER, METAL PEALING WAS OBSERVED. THE SURGEON CLOSELY INSPECTED THE WOUND TO CONFIRM THERE WAS NO METAL RESIDUE IN THE PATIENT AND THE BROKEN INSTRUMENT. THE INSTRUMENTS HAD ALREADY PERFORMED THEIR FUNCTION AND THERE WAS NO FURTHER INCIDENT. THE INSTRUMENTS WERE RETRIEVED ACCORDING TO COMPLAINT HANDLING PROCEDURES FOR EVALUATION AFTER THE CASE COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19768582 ↗
• MalfunctionJun 26, 2024Material Disintegration; Structural Problem; Scratched Material; No Apparent Adverse Event; Material Disintegration; Structural Problem; Scratched Material; No Apparent Adverse Event

  THE CALCAR PLANER INSTRUMENT (PART NUMBER 9110-3003 AND 9110-3002) USED DURING A HIP SURGERY ON (B)(6) 2024 AT THE SURGICAL INSTITUTE OF READING BY THE SURGEON BROKE WHILE GRINDING AND TORQUING THE BROACH TRIAL.METAL SHAVINGS WERE FOUND INSIDE THE INSTRUMENT, THERE WAS NO EVIDENCE OF THEM BEING LEFT IN THE PATIENT'S BODY.THE SURGEON COMPLETED THE CASE USING ANOTHER SIZE CALCAR PLANER, AND THE BROKEN INSTRUMENT WAS RETRIEVED AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19612011 ↗
• InjuryMay 17, 2024Material Disintegration; Structural Problem; Scratched Material; No Apparent Adverse Event; Material Disintegration; Structural Problem; Scratched Material; No Apparent Adverse Event

  THE CALCAR PLANER INSTRUMENT (PART NUMBER 9110-3003 AND 9110-3002) USED DURING A HIP SURGERY ON (B)(6) 2024 AT THE SURGICAL INSTITUTE OF READING BY THE SURGEON BROKE WHILE GRINDING AND TORQUING THE BROACH TRIAL. METAL SHAVINGS WERE FOUND INSIDE THE INSTRUMENT, THERE WAS NO EVIDENCE OF THEM BEING LEFT IN THE PATIENT'S BODY. THE SURGEON COMPLETED THE CASE USING ANOTHER SIZE CALCAR PLANER, AND THE BROKEN INSTRUMENT WAS RETRIEVED AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347048 ↗