NA 72200626Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010562890), received between Dec 4, 2018 and Aug 28, 2022 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Unstable” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2022Unstable; Unstable

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE UNIVERSAL HIP DISTRACTOR WAS NOT HOLDING THE TRACTION VERY WELL. WHEN THE SURGEON WAS WINDING THE TRACTION AND AT A POINT OF HIGH TRACTION, IT WOULD SUDDENLY GAVE AWAY AND LOST ALL TRACTION. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307839 ↗
• InjuryNov 1, 2021Misassembled; Misassembled

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION OF THE UNIVERSAL HIP DISTRACTOR BEFORE ARTHROSCOPY PROCEDURE, IT WAS NOTICED THAT THE CARRIAGE THREAD OF THE LAG "SCREW" HAD BEEN REMOVED, DUE TO THIS NO TRACTION COULD BE APPLIED. THE PATIENT WAS ALREADY ANESTHETIZED AND THE SURGERY WAS POSTPONED 4 HOURS LATER IN THE SAME DAY. DUE TO THE MALFUNCTION / DEFECT, THE LEG COULDN¿T HAVE BEEN BROUGHT INTO EXTENSION. A REPLACEMENT HAS BEEN DELIVERED INTRADAY WITHIN 4 HOURS. THEREFORE THE SURGERY HAS BEEN CANCELED AND POSTPONED FOR THE AFTERNOON. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12733630 ↗
• MalfunctionMar 25, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE HIP DISTRACTOR WAS NOT TIGHTENING ON THE BOOT HOLDER CLAMP. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567860 ↗
• MalfunctionFeb 23, 2021Break; Unstable; Break; Unstable

  IT WAS REPORTED THAT, DURING A HIP SCOPE, THE UNIVERSAL HIP DISTRACTOR KNOB BROKE WHEN IT WAS TURNED. THERE WAS A LOSS OF TRACTION AS A RESULT OF THE KNOB'S MALFUNCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366028 ↗
• MalfunctionDec 4, 2020Unstable; Unstable

  IT WAS REPORTED THAT DURING A SURGERY THE HIP DISTRACTOR BALL ALL JOINT CANNOT HOLD THE BOOT-LEG IN THE POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10945058 ↗
• MalfunctionAug 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE UNIVERSAL HIP DISTRACTOR WAS NOT HOLDING TIGHT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10452312 ↗
• MalfunctionJul 10, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE HIP DISTRACTOR BALL JOINTS WERE EASY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10257449 ↗
• MalfunctionJun 10, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A PROCEDURE, THE UNIVERSAL HIP DISTRACTOR POPPED OUT OF POSITION WHEN DISTRACTING, NO PIECES FELL INSIDE THE PATIENT. THERE WAS A DELAY GREATER THAN 30 MINUTES AND IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10139630 ↗
• MalfunctionAug 28, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A PROCEDURE THE DEVICE'S ORANGE KNOB WAS STICKING, PREVENTING PROPER FUNCTIONALITY. INSTRUMENTS HAD TO BE RETRIEVED FROM WITHIN THE PATIENT BECAUSE OF THE MALFUNCTION. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8941625 ↗
• MalfunctionDec 4, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT'S FOOT SLIPPED OUT OF THE BOOT WHEN TRACTION WAS APPLIED AND THE WHOLE TRACTION LEG NEARLY CAME OFF WHEN THE TRACTION WAS ATTEMPTED TO BE APPLIED. THERE WAS A SIGNIFICANT DELAY, MORE THAN 2 HOURS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8131248 ↗