G7® Acetabular System 110010243Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00887868355875), received between Jul 2, 2020 and Sep 8, 2026 — classified as 12 injuries, 11 malfunctions.

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

• MalfunctionSep 8, 2026Degraded; Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676459 ↗
• InjuryJun 2, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT UNDERWENT A HIP REVISION APPROXIMATELY 1-MONTH POST IMPLANTATION DUE TO INFECTION. DURING THE PROCEDURE, THE CUP BECAME LOOSE WHEN ATTEMPTING TO REMOVE LINER. THE CUP, LINER, HEAD, AND BEARING WERE REVISED. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.

  Patient problems: Aseptic loosening; Medical device site infection; Unspecified Infection

  MAUDE report 25360382 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: Impaired Healing

  MAUDE report 24581774 ↗
• MalfunctionFeb 16, 2026Difficult to Insert

  IT WAS REPORTED THAT THE INSERTER CENTER SCREW BECOMES STUCK, MAKING IT DIFFICULT TO ASSEMBLE WITH THE SHELL. NO PATIENT HARM OR IMPACT REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344153 ↗
• InjuryDec 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY TWO YEARS LATER DUE TO CUP LOOSENING AND A FRACTURED SCREW. IT WAS REPORTED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23694181 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: Aseptic loosening; Bacterial Infection; Bursitis; Medical device site infection; Pain; Septic loosening; Swelling/ Edema

  MAUDE report 23027057 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22936731 ↗
• InjuryJun 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED NEARLY ONE (1) YEAR POST IMPLANTATION DUE TO DISLOCATION. THE LINER WAS EXPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 22168821 ↗
• MalfunctionJan 6, 2025Difficult 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 21080576 ↗
• MalfunctionNov 6, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO REMOVE THE SCREW CAPS FROM THE CUP. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625149 ↗
• InjuryNov 6, 2024Malposition of Device; Malposition of Device

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20622768 ↗
• InjuryOct 15, 2024Malposition of Device; Malposition of Device

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453130 ↗
• InjurySep 9, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Pain

  MAUDE report 20168936 ↗
• MalfunctionAug 5, 2024Positioning Problem; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19910381 ↗
• MalfunctionJun 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN INITIAL HIP PROCEDURE, THE SHELL WAS INSERTED AND THE LINER COULD NOT BE INSERTED. THE ATTEMPT WAS MADE TO INSERT A SECOND LINER, WHICH COULD ALSO NOT BE INSERTED. A SECOND SHELL WAS INSERTED. THE ATTEMPT WAS MADE TO INSERT TWO NEW LINERS AND BOTH COULD NOT BE INSERTED. A THIRD LINER WAS ABLE TO INSERTED INTO THE SHELL TO COMPLETE THE SURGERY. THE SURGEON REPORTED THAT THE SHELL WAS NOT STABLE DURING LINER INSERTION DUE TO FRAGILE BONE QUALITY. THERE WAS A 10-15 MINUTE DELAY TO SURGERY. 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 19547924 ↗
• MalfunctionMay 2, 2024Separation Failure; Separation Failure

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19230227 ↗
• MalfunctionJan 4, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE DUAL MOBILITY RING FOR THE LINER WAS STUCK IN THE SHELL. IT HAD TO BE REMOVED WITH OTHER INSTRUMENTS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SHELL AND LINER. 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 18443674 ↗
• MalfunctionSep 28, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE INSERTER BROKE UPON IMPACTION AND WAS UNABLE TO BE REMOVED FROM THE CUP. A NEW INSTRUMENT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17837355 ↗
• InjurySep 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17719908 ↗
• MalfunctionMay 2, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL HIP ARTHROPLASTY, THE LINER WOULD NOT SEAT UPON THE ACETABULAR SHELL. A SECOND INLAY WAS ATTEMPTED AND THE SAME MALFUNCTION OCCURRED. THE ACETABULAR SHELL WAS THEN REMOVED AND ANOTHER SHELL AND LINER WERE IMPLANTED WITHOUT COMPLICATION. THERE WAS A SURGICAL DELAY OF 20-30 MINUTES TO REPLACE THE SHELL AND LINER BUT NO PATIENT IMPACT HAS BEEN REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16853101 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED (B)(6) 2021. SUBSEQUENTLY, THE PATIENT DEVELOPED A PULMONARY EMBOLISM ON (B)(6) 2021, REQUIRING 1 DAY HOSPITALIZATION. PE RESOLVED WITHOUT FURTHER COMPLICATION. UPON FOLLOW-UP, THE PATIENT REPORTED NO PROBLEMS AND WAS VERY SATISFIED. PATIENT INVOLVED.

  Patient problems: Pulmonary Embolism

  MAUDE report 14368992 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FOURTEEN (14) DAYS POST IMPLANTATION OF THE RIGHT HIP, THE PATIENT DEVELOPED A PULMONARY EMBOLISM, REQUIRING A ONE DAY HOSPITALIZATION. PULMONARY EMBOLISM RESOLVED WITHOUT FURTHER COMPLICATION. UPON FOLLOW-UP, THE PATIENT REPORTED NO PROBLEMS AND WAS VERY SATISFIED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pulmonary Embolism

  MAUDE report 14291009 ↗
• MalfunctionJul 2, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Patient Involvement

  MAUDE report 10226392 ↗