G7 Acetabular Liner 010000925Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00880304527010), received between Dec 15, 2020 and Mar 21, 2025 — classified as 5 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (18 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 21665571 ↗
• MalfunctionJun 25, 2024Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608887 ↗
• MalfunctionJun 24, 2024Difficult to Insert; Difficult to Insert

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19597030 ↗
• MalfunctionJun 7, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER COULDN'T ASSEMBLE MATING THE CUP. THERE WAS A 1 HOUR DELAY TO OBTAIN REPLACEMENT LINER. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482867 ↗
• MalfunctionMay 20, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER CANNOT ASSEMBLE THE MATING THE CUP. REPEATED ATTEMPTS WERE MADE BY THE SURGEON TO IMPLANT THE LINER AT THE CORRECT ANGLE, AND IT STILL FAILED. THERE WAS A TEN-MINUTE DELAY. A BACK-UP LINER WAS USED TO COMPLETE THE SURGERY. THERE WERE NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350273 ↗
• MalfunctionMar 11, 2024Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED. ALTHOUGH IT WAS INITIALLY REPORTED THAT A LARGER CUP AND LINER WERE IMPLANTED, IT WAS SINCE DETERMINED THAT THE LARGER CUP AND LINER WERE NOT ACTUALLY USED. INSTEAD, THE CUP AND LINER THAT WOULD NOT LOCK WERE SOAKED IN COLD WATER FOR 10-MINUTES, AND THEN THE PRODUCTS WERE SUCCESSFULLY IMPLANTED. THERE WAS NOT A 35-MINUTE DELAY AS INITIALLY REPORTED, THERE WAS ACTUALLY A 15-MINUTE DELAY DUE TO THE SOAK. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18877498 ↗
• InjuryFeb 21, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A RIGHT TOTAL HIP PROCEDURE, THE LINER DID NOT LOCK INTO THE ACETABULUM PROPERLY. THE LINER WAS REPLACED WITH THE SAME TYPE OF LINER AND IMPLANTED WITHOUT ANY PROBLEMS. THERE WAS A 40-MINUTE DELAY. IT WAS REPORTED THAT THE SURGEON HAD EXTENSIVE EXPERIENCE AND HAD USE THE PRODUCT BEFORE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AND NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. THE PATIENT WAS DESCRIBED AS WELL PROPORTIONED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18752194 ↗
• MalfunctionJan 9, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER WOULD NOT SEAT PROPERLY DURING A TOTAL HIP REPLACEMENT SURGERY. DURING SURGERY, THERE WAS A MISMATCH BETWEEN THE LINER AND CORRESPONDING CUP. IT WAS REPORTED THAT THERE WAS A TWENTY-MINUTE DELAY IN SURGERY. THE LINER COULD NOT BE IMPLANTED AND WAS REPLACED WITH A CORRESPONDING CERAMIC LINER FOR NORMAL IMPLANTATION. SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO ADVERSE PATIENT IMPACT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18478363 ↗
• MalfunctionNov 9, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL HIP PROCEDURE, THE LINER WOULD NOT IMPLANT INTO THE CUP, WHICH RESULTED IN A THIRTY MINUTE DELAY. A DIFFERENT LINER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100697 ↗
• MalfunctionNov 8, 2023Difficult to Insert; Difficult to Insert

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093360 ↗
• MalfunctionNov 6, 2023Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072999 ↗
• InjuryAug 16, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED ON THAT DURING A PROCEDURE, AN UNKNOWN EVENT CAUSING LEFT FEMORAL FRACTURE IN A PATIENT WITH HISTORY OF PREVIOUS LEFT FEMORAL NECK FRACTURE AND MODERATE ANEMIA WITH NO REPORT OF PREVIOUS THA. DURING THE SURGERY ENCOUNTERED EBL 1500 ML DUE TO PATIENTS LEFT INTER-ROTOR FRACTURE COMBINED WITH THE OLD FRACTURE OF NECK OF FEMUR, AND THE LOCAL SOFT TISSUE EDEMA AND ADHESION, THAT CAUSED A LOT OF BLEEDING DURING THE OPERATION. PATIENT WAS TRANSFUSED WITH 9 UNITS OF RBC AND 950 ML OF FFP DURING THE EXTENDED SURGICAL REPAIR OF FRACTURE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17558736 ↗
• InjuryAug 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED TWELVE DAYS POST OP DUE TO DISLOCATION. PER SALES REP, THE VERSION OF THE ACETABULAR CUP WAS TOO ANTEVERTED AND THE ORIGINATION OF THE HIGHWALL LINER WAS CAUSING LEVERAGE MAKING THE FEMORAL HEAD DISLOCATE ANTERIORLY. SURGEON BELIEVES THE ORIGINATION OF THE CUP WAS FINE AND THAT IT WAS DUE TO A NON-COMPLIANT PATIENT. THE PATIENT HAD A SHUFFLE GAIT AND DID NOT WANT TO FOLLOW POST OPERATIVE PROTOCOL, PER SURGEON. THE STEM, HEAD, AND LINER WERE EXCHANGED. NO ALLEGATIONS AGAINST THE STEM AS IT WAS REMOVED BECAUSE THE SURGEON KNOCKED THE FEMORAL HEAD HARD DISLODGING THE STEM.

  Patient problems: Joint Dislocation

  MAUDE report 17470882 ↗
• MalfunctionFeb 23, 2023Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMAITON TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16430617 ↗
• MalfunctionFeb 22, 2023Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16419240 ↗
• MalfunctionJan 31, 2023Difficult to Insert; Difficult to Insert

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271725 ↗
• MalfunctionJan 19, 2023Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16205641 ↗
• InjuryDec 13, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE OPERATION, THE ACETABULAR CONTUSION WAS GROUND TO 47-48 AND THEN THE G7 CUP OF 48 WAS PLACED, THE CUP WAS CLEANED WITH WATER AND THEN THE PROSTHESIS E1 HIGH SIDE LINER MODEL C WAS PUT ON, THE DIRECTOR TAPPED DURING THE OPERATION AND FOUND THAT THE G7 CUP AND THE LINER WERE STILL NOT LOCKED, THE LINER COULD STILL BE CLAMPED OUT, AFTER REPEATED CHECKS, THERE WAS NO PROBLEM AND REMINDED THE DIRECTOR OF THE FORCE OF TAPPING AND THE ANGLE OF STRIKING THE LINER, THE LINER STILL COULD NOT BE LOCKED, AFTER UP TO 10 MINUTES OF REPEATED AFTER REPEATED CHECKS AND CLEANUPS FOR UP TO 10 MINUTES, THE LINER STILL COULD NOT BE LOCKED. DUE TO THE PATIENT'S BONE QUALITY, AFTER THE FINAL DISCUSSION OF THE RESULTS, THE CERAMIC LINER MODEL C WAS DISMANTLED AND STRUCK IN AT ONCE, AND THE SHANK PART WAS FINALLY IMPLANTED TO COMPLETE THIS SURGERY. THE RESULT OF THIS INCIDENT: THE DIRECTOR QUESTIONED THE LOCKING MECHANISM AND QUALITY OF THIS PRODUCT, WHICH PROLONGED THE OPERATION AND MADE THE PATIENT BLEED. AS A RESULT, THE PATIENT REQUIRED A BLOOD TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15971514 ↗
• MalfunctionJul 12, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AFTER THE CUP WAS INSTALLED AND THE LINER WAS NOT TIGHTENED THE FIRST TIME, THE CUP WAS RINSED AND CHECKED AND THEN KNOCKED AGAIN, BUT THE LINER STILL COULD NOT BE TIGHTENED. SINCE THE PATIENT HAD SEVERE OSTEOPOROSIS AND DID NOT DARE TO USE TOO MUCH FORCE, THE SURGEON FOUND THAT THE CUP WAS SUNK IN AND THE LINER WAS STILL NOT TIGHTENED, SO THE CERAMIC LINER WAS USED INSTEAD. THERE WAS A 10 (TEN) MINUTE DELAY TO REMOVE THE SCREWS AND REPLACE THE NEW LINER. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988921 ↗
• MalfunctionAug 3, 2021Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12265955 ↗
• MalfunctionAug 3, 2021Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12265949 ↗
• MalfunctionDec 15, 2020Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11011212 ↗