NA 2244-10-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295107484), received between Sep 5, 2018 and May 22, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Mechanical Jam

  IT WAS REPORTED THAT THE VERSION GUIDE WAS STUCK. IT WOULD NOT TURN ANYMORE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254601 ↗
• MalfunctionApr 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. EVENT DID NOT HAPPEN IN SURGERY. INVESTIGATION SHOWED THE DEVICES WERE STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916040 ↗
• MalfunctionApr 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. EVENT DID NOT HAPPEN IN SURGERY. INVESTIGATION SHOWED THE DEVICES WERE STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915956 ↗
• MalfunctionApr 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. EVENT DID NOT HAPPEN IN SURGERY. INVESTIGATION SHOWED THE DEVICES WERE STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915843 ↗
• MalfunctionApr 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. EVENT DID NOT HAPPEN IN SURGERY. INVESTIGATION SHOWED THE DEVICES WERE STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915807 ↗
• MalfunctionApr 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. EVENT DID NOT HAPPEN IN SURGERY. INVESTIGATION SHOWED THE DEVICES WERE STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915709 ↗
• MalfunctionFeb 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT BOTH ITEMS ARE NO LONGER IN ALIGNMENT, THE ROD IS BENT.

  Patient problems: Insufficient Information

  MAUDE report 21457841 ↗
• MalfunctionFeb 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT BOTH ITEMS ARE NO LONGER IN ALIGNMENT, THE ROD IS BENT.

  Patient problems: Insufficient Information

  MAUDE report 21457815 ↗
• MalfunctionSep 23, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE ALIGNMENT ROD STUCK AND FROZEN. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278001 ↗
• MalfunctionApr 22, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING CONVERSION TO TOTAL HIP ARTHROPLASTY, THE VERSION GUIDE FOR THE STRAIGHT CUP IMPACTOR WOULD NOT CHANGE ITS ANGLE AND STAYED STUCK AT ZERO. THERE ARE NO BROKEN PIECES. THERE WAS NO COMPLICATION OR DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159551 ↗
• MalfunctionDec 19, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE GUIDE WON'T MOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356569 ↗
• MalfunctionAug 15, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ROD ON THE HIP ANGLE GUIDE IS BENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 17550547 ↗
• MalfunctionJul 28, 2023Incorrect Measurement; Mechanical Jam; Incorrect Measurement; Mechanical Jam

  UPON INSPECTION OF INSTRUMENT PRIOR TO SURGERY, IT WAS DISCOVERED THAT THE TAIL DOES NOT ROTATE AS IT SHOULD. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17416379 ↗
• MalfunctionMay 4, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CUP ANTEVERSION GUIDE ROD BENT SO IT IS OUT OF CALIBRATION. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16867403 ↗
• MalfunctionMar 29, 2023Break; Break

  IT WAS REPORTED ,THAT WHEN CLEANING INSTRUMENTS THE DAY AFTER, CASE NOTICED THAT THE VERSION GUIDE OUT OF PINN POLY TRAY HAD BROKEN. VERSION ROD IS DETACHED FROM HANDLE THAT FITS OVER IMPACTOR. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635330 ↗
• MalfunctionNov 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PINNACLE ALIGNMENT GUIDE WOULD GET STUCK WHEN TRYING TO ADJUST THE AMOUNT OF VERSION (ROD WOULD NOT ROTATE TO DIFFERENT ANGLES). T-HANDLE FORMED A CRACK IN THE PLASTIC PORTION OF THE HANDLE. LARGE CALCAR PLANER BECAME DULL AND NO LONGER WORKED AS INTENDED. THERE WAS 5 MINUTES SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15723438 ↗
• MalfunctionJul 11, 2022Break; Illegible Information; Break; Illegible Information

  IT WAS REPORTED THAT A WHITE SUBSTANCE CAME OUT OF THE SPACE BETWEEN THE SILVER TOP OF THE HANDLE AND THE GRIP OF THE HANDLE WHEN IMPACTED. UNABLE TO READ THE LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982038 ↗
• MalfunctionJun 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ALIGNMENT GUIDE IS BENT. NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11969485 ↗
• MalfunctionJun 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE AIMING ROD WAS BENT AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967350 ↗
• MalfunctionApr 30, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE ALIGNMENT GUIDE WOULD NOT SET TO 0 DEGREES. THEREFORE THE OTHER ALIGNMENT ANGLES HAD TO BE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11756950 ↗
• MalfunctionFeb 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ALIGNMENT ROD WAS BENT AND NEEDS REPLACING. SHIP TO EAST COOPER P1. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282645 ↗
• MalfunctionFeb 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ARM OF THE ACETABULAR ALIGNMENT GUIDE IS BENT. NO DELAY TO SURGERY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11281131 ↗
• MalfunctionJan 6, 2021Break; Break

  IT WAS REPORTED THAT THE PINNACLE ALIGNMENT GUIDE WAS BROKEN IN HALF. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127453 ↗
• MalfunctionJan 6, 2021Break; Break

  IT WAS REPORTED THAT THE PINNACLE ALIGNMENT GUIDE WAS BROKEN IN HALF. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127448 ↗
• MalfunctionSep 18, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATED THAT "WELDED POST WAS BACKING OUT OF AIMING DEVICE" MEANS THE POST THAT HOLDS THE ALIGNMENT IN PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10555483 ↗