G7 Acetabular Liner 010000924Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304527003), received between Oct 21, 2021 and Mar 18, 2024 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024Difficult 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 18925329 ↗
• 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 17558744 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, AT APPROXIMATELY EIGHT MONTHS POST-OP THE PATIENT DEVELOPED PERSISTENT LATERAL THIGH AND GROIN PAIN. TENDONITIS WAS SUSPECTED HOWEVER, THE SURGEON ALSO QUESTIONED IF THERE WAS AN ISSUE WITH THE PRESS-FIT FEMORAL COMPONENT. APPROXIMATELY 9 MONTHS POST-OP, AN INJECTION OF STEROIDS AND LOCAL ANESTHETIC WAS GIVEN UNDER FLUOROSCOPIC GUIDANCE. THE PATIENT HAS SINCE COMPLETED THE STUDY WITH IMPROVEMENT IN PAIN AND ALL IMPLANTS REMAINING IN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Inflammation; Pain

  MAUDE report 17388234 ↗
• MalfunctionFeb 2, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LINER WOULD NOT FIT SECURELY INTO THE SHELL. ANOTHER LINER WAS USED, AND THAT FIT SECURELY. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286820 ↗
• MalfunctionJul 12, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE LINER WOULD NOT TIGHTEN INTO THE CUP PROPERLY. A NEW LINER WAS USED TO COMPLETE THE SURGERY. THERE WAS NO HARM OR INJURY TO THE PATIENT. 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 14989788 ↗
• MalfunctionJul 6, 2022Difficult or Delayed Positioning; Difficult to Insert; Difficult or Delayed Positioning; Difficult to Insert

  IT WAS REPORTED DURING THE OPERATION WITH THE G7 CUP, INSERT B WAS STUCK TO THE 46 CUP ALREADY IMPLANTED, DESPITE THE INTERNAL CLEANING OF THE CUP, THE BLOWS GENERATED BY THE BEATING CAUSED THE DISASSEMBLY OF THE CUP FORCING THE SURGEON TO IMPLANT A NEW CUP OF A LARGER SIZE THAN THE ANATOMY OF THE PATIENT. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14929641 ↗
• MalfunctionMar 9, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AFTER THE INTRAOPERATIVE ACETABULAR WAS REAMED TO A 45 AND PLACING THE 46MM G7 CUP IMPLANT, THE TRIAL LINER WAS PUT IN. THEN, THE OVERALL TRIAL WAS COMPLETED AND THE ANGLE WAS FOUND TO BE SUITABLE. THEREFORE, THE 32/B HIGH WALL LINER WAS OPENED AS REQUESTED BY THE SURGEON. THE SURGEON FIRST CLEANED THE SOFT TISSUE AROUND THE CUP EDGE, CHECKED THE ACETABULAR BASE AND THEN STRUCK THE LINER. HOWEVER, THE G7 LINER DID NOT LOCK INTO PLACE. THE SURGEON CLEANED THE SOFT TISSUE AROUND THE CUP, THE BONE BULGE, AGAIN CHECKED THE ANGLE AND STRUCK THE LINER, BUT IT STILL WOULD NOT LOCK. THE SURGEON REPEATED CHECKS AND CLEANUPS FOR UP TO 20 MINUTES, BUT THE LINER WOULD NOT LOCK INTO PLACE. DUE TO THE PATIENT'S BONE QUALITY PROBLEM, THE PATIENT ENDED UP WITH A COLLAPSED ACETABULUM. A CERAMIC LINER, A G7 CUP, AND THE BOTTOM OF THE ACETABULUM WAS FILLED WITH AUTOLOGOUS BONE AND ALLOGENEIC BONE TO COMPLETE THE PROCEDURE. AS A RESULT OF THE MALFUNCTION, THE PROCEDURE WAS PROLONGED AND CAUSED BLEEDING TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Osteopenia/ Osteoporosis

  MAUDE report 13709265 ↗
• MalfunctionOct 21, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING AN INITIAL HIP ARTHROPLASTY THE SURGEON COULD NOT GET THE FIRST G7 HIGHWALL LINER TO SEAT. SURGEON HAD TO ENSURE THE INTERIOR OF THE SHELL IS DRY AND FREE OF DEBRIS, OVERHANGING SOFT TISSUE WAS REMOVED. SURGEON MANUALLY PLACED THE LINER INTO THE SHELL, ENSURING THE SCALLOPS WERE CORRECTLY ALIGNED WITH THE RECESSED AREAS ON THE SHELL. APPLYING MANUAL PRESSURE TO THE DOME REGION TO PROVISIONALLY SECURE THE LINER IN PLACE BY LIGHTLY ENGAGING THE SCALLOPS. UTILIZING THE APPROPRIATELY SIZED G7 BALL IMPACTOR, PLACED THE TIP OF THE IMPACTOR ON THE DOME OF THE LINER WITH THE HANDLE PERPENDICULAR TO THE FACE OF THE SHELL. AFTER SEVERAL ATTEMPTS, SURGEON OPENED THE SECOND LINER. MULTIPLE ATTEMPTS WITH SAME TECHNIQUE, SURGEON WAS FINALLY ABLE TO GET SECOND LINER TO SEAT. 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 12671580 ↗
• MalfunctionOct 21, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED DURING AN INITIAL HIP ARTHROPLASTY THE SURGEON COULD NOT GET THE FIRST G7 HIGHWALL LINER TO SEAT. SURGEON HAD TO ENSURE THE INTERIOR OF THE SHELL IS DRY AND FREE OF DEBRIS, OVERHANGING SOFT TISSUE WAS REMOVED. SURGEON MANUALLY PLACED THE LINER INTO THE SHELL, ENSURING THE SCALLOPS WERE CORRECTLY ALIGNED WITH THE RECESSED AREAS ON THE SHELL. APPLYING MANUAL PRESSURE TO THE DOME REGION TO PROVISIONALLY SECURE THE LINER IN PLACE BY LIGHTLY ENGAGING THE SCALLOPS. UTILIZING THE APPROPRIATELY SIZED G7 BALL IMPACTOR, PLACED THE TIP OF THE IMPACTOR ON THE DOME OF THE LINER WITH THE HANDLE PERPENDICULAR TO THE FACE OF THE SHELL. AFTER SEVERAL ATTEMPTS, SURGEON OPENED THE SECOND LINER. MULTIPLE ATTEMPTS WITH SAME TECHNIQUE, SURGEON WAS FINALLY ABLE TO GET SECOND LINER TO SEAT. 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 12671557 ↗