GLOBAL ADVANTAGE 2128-01-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295088073), received between Jul 5, 2017 and Jun 26, 2024 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT DURING THE EXTRACTION OF THE FEMORAL STEM THE THREADED SLAP HAMMER ATTACHMENT BROKE OFF INTO THE ACTIS EXTRACTION HANDLE.

  Patient problems: Insufficient Information

  MAUDE report 19620179 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT THE END OF INSTRUMENT BROKE WHILE USING WITH SLAP HAMMER ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19058055 ↗
• MalfunctionJun 5, 2023Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING A HIP REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061372 ↗
• MalfunctionJun 5, 2023Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING A HIP REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060264 ↗
• MalfunctionMar 29, 2023Break; Illegible Information; Break; Illegible Information

  ADDITIONAL INFORMATION RECEIVED. CONFIRMED, THAT THE EXTRACTED FEMORAL STEM MENTIONED IS NOT A DEPUY PRODUCT. LOT NUMBER WAS ILLEGIBLE IN THE ADAPTERS. IT WAS THE THREADED PART THAT BROKE FROM THE BODY. THERE WERE NO PIECES LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639945 ↗
• MalfunctionMar 29, 2023Break; Illegible Information; Break; Illegible Information

  ADDITIONAL INFORMATION RECEIVED. CONFIRMED, THAT THE EXTRACTED FEMORAL STEM MENTIONED IS NOT A DEPUY PRODUCT. LOT NUMBER WAS ILLEGIBLE IN THE ADAPTERS. IT WAS THE THREADED PART THAT BROKE FROM THE BODY. THERE WERE NO PIECES LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639942 ↗
• MalfunctionJan 12, 2023Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT IS SLAPPING OUT AND A BOLT BROKE INTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16150112 ↗
• MalfunctionJan 12, 2023Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT IS SLAPPING OUT AND A BOLT BROKE INTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16150097 ↗
• MalfunctionApr 14, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE BOLT ON SLAP HAMMER BECAME CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110775 ↗
• MalfunctionFeb 22, 2022Break; Break

  THE THREADS ON THREADED ADAPTER BROKE OFF IN SLAP HAMMER DURING USE. NO PATIENT HARM OR SURGICAL DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579907 ↗
• MalfunctionJun 22, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED AS "ONE SIDE OF THE MALE ON MALE ADAPTOR WAS EXCESSIVELY STRIPPED AND THUS NO LONGER USABLE. IT WAS NOT USED ON A PATIENT AND WILL BE SENT BACK TO DEPUY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12043441 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT WHILE ATTEMPTING TO EXTRACT THE STEM THE MALE ON MALE ADAPTER WAS BROKEN OFF INSIDE THE SROM SLAP HAMMER. ON SET OF THE MALE ON MALE IS LODGED INSIDE THE TIP OF THE SLAP HAMMER. ALL PIECES WERE REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615621 ↗
• MalfunctionSep 18, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO BROACH THE FEMORAL CANAL OF PATIENT INDICATED ABOVE. THE BROACH GOT STUCK IN THE CANAL, SO THEY HAD TO OPEN THE STEM REMOVAL TRAY, WHICH INCLUDED A DEPUY SLAP HAMMER. WITH THE USE OF A DEPUY ADAPTER, THE SLAP HAMMER WAS ATTACHED TO THE STEM DISTRACTOR AND AN ATTEMPT WAS MADE TO REMOVE THE BROACH FROM THE PATIENT'S CANAL. UNFORTUNATELY, IN THE PROCESS, THE SLAP HAMMER AND ADAPTER WAS DAMAGED BEYOND REPAIR. TO REVIEW. ONE SLAP HAMMER WAS DAMAGED AS WELL AS ONE ADAPTER, THE CASE WAS DELAYED , BUT THE SURGEON UNDERSTOOD , CONSIDERING THE CIRCUMSTANCES. ALL BROKEN PIECES WERE RETRIEVED AND HE APOLOGIZED FOR THE DAMAGE. THERE WAS 90 MINUTES SURGICAL DELAY.

  Patient problems: No Code Available

  MAUDE report 10554502 ↗
• MalfunctionApr 9, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS WERE DAMAGED DURING CLEANING PROCESS AFTER SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943927 ↗
• MalfunctionJan 9, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASONS. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 9573167 ↗
• MalfunctionDec 9, 2019Break; Break

  IT WAS REPORTED THAT THE SLAP HAMMER ADAPTER WAS BROKEN OFF IN THE STEM INSERTER. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9439599 ↗
• MalfunctionOct 25, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  THREADS ARE DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241674 ↗
• MalfunctionMar 27, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE FEMALE THREADING STRIPPED. DAMAGED MALE THREADING DURING USE. IT WAS INDICATED BY THE SALES REP THAT NO PIECES CAME OFF THE THREADING AND NO PIECES WERE IN THE PATIENT. THREADS ARE SHEARING OFF. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455299 ↗
• MalfunctionAug 7, 2018Break; Break

  IT WAS REPORTED THAT WHILE SLAP HAMMERING OUT A GLOBAL AP STEM, THE THREADED ADAPTOR THAT LINKS THE GLOBAL AP INSERTION HANDLE AND A SLAP HAMMER THE THREADED ADAPTOR BROKE. SOME OF THIS THREADS BROKE. ALL PIECES WERE RECOVERED AND WE PROCEEDED TO REMOVE THE STEM THROUGH AN ALTERNATIVE METHOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7756570 ↗
• MalfunctionMar 6, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS WERE STRIPPED DURING EXTRACTION OF IMPLANT. BOTH PARTS WERE TAKEN OFF FIELD AND ARE BEING SENT BACK. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7315933 ↗
• MalfunctionJul 27, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE THREAD STRIPPED DURING SURGERY TRYING TO REMOVE STEM.

  Patient problems: No Information

  MAUDE report 6747003 ↗
• MalfunctionJul 24, 2017Break; Break

  IT WAS REPORTED THAT THE MALE ON MALE ADAPTER THREAD WAS SNAPPED OFF IN THE END.

  Patient problems: No Information

  MAUDE report 6737139 ↗
• MalfunctionJul 5, 2017Break; Break

  IT WAS REPORTED THAT THE THREADED ADAPTOR BROKE WHEN USED.

  Patient problems: No Information

  MAUDE report 6685811 ↗