NA A6779Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 10603295255611), received between Aug 1, 2017 and Apr 9, 2026 — classified as 1 injury, 127 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (42 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 25 most recent of 128 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENTS THREAD WAS WORN ON THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24833003 ↗
• MalfunctionApr 2, 2026Material Deformation

  IT WAS REPORTED THAT THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THE THREADS ON THESE PIECES OF EQUIPMENT ARE STRIPPED AND NO LONGER FUNCTION PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764156 ↗
• MalfunctionApr 2, 2026Material Deformation

  IT WAS REPORTED THAT THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THE THREADS ON THESE PIECES OF EQUIPMENT ARE STRIPPED AND NO LONGER FUNCTION PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764149 ↗
• MalfunctionApr 2, 2026Material Deformation

  IT WAS REPORTED THAT THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THE THREADS ON THESE PIECES OF EQUIPMENT ARE STRIPPED AND NO LONGER FUNCTION PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764131 ↗
• MalfunctionFeb 24, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIP WAS WORN OUT AND DID NOT SCREW INTO THE FEMORAL STEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430687 ↗
• MalfunctionDec 12, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE METAL WAS BENT BY USE, IT CAN NO LONGER BE ATTACHED TO THE FEMORAL STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789475 ↗
• MalfunctionDec 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SLAP HAMMER M6/M10 ADAPTATOR CROSS THREADED. THE EVENT WAS NOTICED BY THE CENTRAL STERILE SUPPLY DEPARTMENT (CSSD) AFTER A TOTAL HIP REPLACEMENT SURGERY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705534 ↗
• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED A BLOT ON THE SLAP HAMMER ADAPTOR FROM THE CORAIL REVISION TRAY BROKE DURING A PROCEDURE ON (B)(6) 2025. THERE WAS NO SURGICAL DELAY OR ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923954 ↗
• MalfunctionJul 31, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS WERE DAMAGED ON THE CORAIL EXTRACTOR. THEY WERE STRIPPED, DENTED, AND WARPED DUE TO PREVIOUS USAGE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676155 ↗
• MalfunctionJun 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADED EXTRACTOR THREADS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359679 ↗
• MalfunctionJun 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE THREE-PIECE EXTRACTOR WAS UNABLE TO BE SEPARATED DURING THE PROCEDURE. THE PROSTHESIS WAS ABLE TO BE EXTRACTED AND THE CASE WAS COMPLETED. THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203791 ↗
• MalfunctionApr 29, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SCREW END OF THE SLAP HAMMER BECAME BENT AND WAS NOT ABLE TO ATTACH TO THE BROACH/STEM. THERE WAS NO DELAY TO THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925424 ↗
• MalfunctionMar 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADING STRIPPED ON THE CORAIL SLAP HAMMER. THE PROCEDURE WAS DELAYED BY 10 MINUTES DUE TO THE EVENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655382 ↗
• MalfunctionMar 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CORAIL-SUMMIT EXTRACTOR THREADING WAS BUSTED MID-CASE. SURGERY WAS DELAYED BY 15 MINUTES DUE TO THE EVENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525666 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING A REVISION HIP SURGERY, THE SLAP HAMMER WAS USED. DURING THE SURGERY, THE SURGEON ATTACHED THE SLAP HAMMER TO A DESIGNATED SCREW IN THE STEM AND STRUCK THE SLAP HAMMER SEVERAL TIMES WITH A HAMMER TO ASSESS THE GRIP OF THE ORIGINAL STEM WITHIN THE BONE. AFTER SEVERAL HAMMER STRIKES, THE TIP OF THE SLAP HAMMER BROKE INSIDE THE STEM. AFTER EXAMINATION, IT WAS DETERMINED THAT THE TIP OF THE SLAP HAMMER THAT BROKE WAS WELL SCREWED INTO THE THREAD OF THE STEM, AND THUS IT WAS DECIDED TO LEAVE IT INSIDE THE STEM. AS PART OF THE SURGERY, THE SURGEON DECIDED TO REPLACE THE ORIGINAL CERAMIC HEAD WITH A NEW CERAMIC HEAD AND COMPLETED THE REVISION SURGERY TO HIS SATISFACTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21433859 ↗
• MalfunctionFeb 11, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THE CORAIL THREADED ADAPTOR IS BROKEN. THE THREAD IS WORN. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354025 ↗
• MalfunctionJan 16, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PRODUCT IS CROSS THREADED AND NO LONGER THREADS PROPERLY INTO A FEMORAL STEM. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170304 ↗
• MalfunctionJan 16, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PRODUCT IS CROSS THREADED AND NO LONGER THREADS PROPERLY INTO A FEMORAL STEM. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170282 ↗
• MalfunctionDec 26, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024. DURING THE PROCEDURE, THE THREADS ON EXTRACTORS WERE STRIPPED. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018665 ↗
• MalfunctionSep 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ARE STRIPPED AND ARE NOW UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224697 ↗
• MalfunctionSep 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE THREAD ON THE DISTAL END OF THE SLAP HAMMER SHEARED OFF INSIDE THE ADAPTER INSTRUMENT IT CONNECTS TO DURING USE RENDERING IT UNUSABLE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT NOR WAS SURGERY TIME INCREASED SIGNIFICANTLY. THE SURGEON SIMPLY USED ANOTHER INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162656 ↗
• MalfunctionJun 25, 2024Naturally Worn; Naturally Worn

  BROKEN CORAIL NECK TRIAL AND DAMAGED CORAIL EXTRACTOR THREAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610659 ↗
• MalfunctionJun 18, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE CORAIL EXTRACTION BOLT WAS CROSS-THREADED, WHICH MEANT IT COULDN¿T SCREW INTO THE CORAIL STEM AS REQUIRED. OPENED A NEW INSTRUMENT AND USED THAT WITH SUCCESS. SURGERY WAS DELAYED 2 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557142 ↗
• MalfunctionMay 7, 2024Break; Break

  IT WAS REPORTED THAT THE THREADED EXTRACTOR BROKE IN THE STEM WHILE USING THE SLAP HAMMER TRYING TO EXTRACT THE STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258284 ↗
• MalfunctionApr 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  MATCH ISSUE. IT WAS REPORTED THAT BEFORE THE SURGERY, NOTED THAT THE RETAINING STEM INSERTER DID NOT MATCH WITH THE EXTRACTION ROD, AND THE THREADS COULD NOT COMPLETELY CONNECTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011532 ↗