GLOBAL AP 2130-01-075Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295090588), received between Sep 26, 2017 and Jan 27, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2022Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT DURING A HIP REVISION OF A PINNACLE CUP TWO IMPACTION HANDLES SNAPPED OFF THE BACK DURING INSERTION OF THE REPLACEMENT CUP. THE IMPACTOR SHEERED THE ROTATING KNOB ON THE BACK OF THE IMPACTORS. FOUR SET ARE AVAILABLE IN HOUSE SO SURGICAL DELAY WAS NO MORE THAN 5 MINUTES TO BRING UP REPLACEMENTS. NO PATIENT KNOWN CONSEQUENCES SURGERY WAS COMPLETED OTHERWISE WITHOUT INCIDENT. ADDITIONAL DURING A CLEANING OF THE GLOBAL AP SET THE AP BROACH EXTRACTOR WAS NOTED TO BE DAMAGED. THE HANDLE STILL FUNCTIONS BUT THE WELD APPEAR TO HAVE BROKEN AND THE HANDLE NOW FREELY SPINS. NO SURGICAL INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366103 ↗
• MalfunctionMar 10, 2021Unintended Movement; Unintended Movement

  THE BASE OF THE HANDLE OF THE STEM INSERTER BECAME LOOSE, ALLOWING IT TO SLIDE DOWN THE SHAFT OF THE INSERTER, AFTER THE SURGEON HAMMERED IT (IN THE CORRECT LOCATION) IN AN ATTEMPT TO REMOVE A STEM. THIS OCCURRED DURING A REVISION CASE WHERE A GLOBAL AP WAS BEING REMOVED. THE SURGEON WAS ABLE TO USE OTHER INSTRUMENTS WITHIN OUR SHOULDER EXTRACTION TRAYS TO SUCCESSFULLY REMOVE THE STEM AND COMPLETE THE OPERATION SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457144 ↗
• MalfunctionSep 26, 2017Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE GLOBAL AP EXTRACTION HANDLE STRIKE PLATE IS LOOSE AND SLIDES UP AND DOWN THE ROD. IT WAS FOUND THAT WAY AFTER OPENING SET FOR THE CASE.

  Patient problems: No Information

  MAUDE report 6895002 ↗