G7® Acetabular System 110010245Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00887868355899), received between Mar 30, 2022 and Apr 24, 2026 — classified as 7 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. THE PATIENT WAS REVISED APPROXIMATELY TWO WEEKS LATER DUE TO MALPOSITION, INCORRECT SIZING, DISLOCATION AND INSTABILITY. IT WAS REPORTED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 24982180 ↗
• InjuryFeb 5, 2026Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 3 YEARS LATER DUE TO ILIOPSOAS PAIN FROM CUP OVERHANG DUE TO LACK OF MEDIALIZATION. DURING THE REVISION, THE CUP WAS REVISED AND DECREASED THE EXPOSED CUP ANTEROSUPERIOR. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 24268518 ↗
• MalfunctionOct 15, 2025Difficult to Insert; Difficult to Insert

  NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292073 ↗
• MalfunctionAug 11, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770593 ↗
• InjuryJun 23, 2025Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISASSOCIATION. THE LINER DISASSOCIATED FROM THE CUP. THE LINER AND CUP WERE EXPLANTED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 22308325 ↗
• MalfunctionFeb 5, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER WAS UNABLE TO BE INSERTED INTO THE CUP. THE SURGEON SUGGESTED POSSIBLE POOR BONE QUALITY OR ANGULATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313549 ↗
• InjuryNov 5, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED ON TWO (2) YEARS POST IMPLANTATION DUE TO PAIN AND IMPINGEMENT. THE CUP AND LINER WERE REVISED DUE TO POSITIONING. THE SURGEON IS UNSURE IF THE PATIENT SUFFERED FROM AN INFECTION AS WELL.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20609012 ↗
• MalfunctionOct 29, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING AN INITIAL HIP ARTHROPLASTY, THE G7 NEUTRAL POLY LINER WOULD NOT SEAT PROPERLY WITHIN G7 OSEOTI LIMITED HOLE SHELL. THE SHELL HAD TWO SCREWS INSITU AND SURGEON TRIED TO SEAT A 36 NEUTRAL POLY LINER USING STANDARD PROCEDURE WITH THE STRAIGHT LINER IMPACTOR. THE SURGEON ALSO TRIED UTILIZING THE SMALLER IMPACTOR SIZES TO PROVIDE MORE ROOM FOR THE PLASTIC LOCKING RING TO ENGAGE AND IT WOULD NOT SEAT. THE SURGEON PROCEEDED TO ATTEMPT WITH TWO MORE POLY LINER OPTIONS, INCLUDING ANOTHER 36MM NEUTRAL AND THEN A 40MM NEUTRAL POLY LINER. SURGEON DETERMINED A FAULT IN THE SHELLS LOCKING RING MECHANISM AND PROCEEDED WITH DUAL MOBILITY, WHICH THEN SEATED INSTANTLY. THREE LINERS WERE DISCARDED IN THE PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560318 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BILATERAL PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTH AGO. DURING THE INITIAL IMPLANTATION, THE PATIENT'S PELVIS FRACTURED. SUBSEQUENTLY, THE PATIENT WAS LATER REVISED APPROXIMATELY SEVEN (7) MONTHS POST-IMPLANTATION TO RECEIVE A PMI DEVICE DUE TO THE PELVIC FRACTURE FROM THE INITIAL IMPLANTATION AND LIMITED BONE STOCK. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Osteopenia/ Osteoporosis

  MAUDE report 19116455 ↗
• InjuryApr 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY SIX WEEKS POST IMPLANTATION DUE TO A DISASSOCIATION. THE LINER WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19078604 ↗
• InjuryJan 19, 2024Positioning Failure; Positioning Failure

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 18545381 ↗
• MalfunctionDec 29, 2023Mechanical Jam; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418139 ↗
• MalfunctionSep 1, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AFTER THE ACETABULAR CUP WAS IMPACTED, A SCREW WAS DRILLED APPROPRIATELY, AND SCREW PLACEMENT WAS PERFORMED. THE SCREW THAT WAS DRIVEN IN APPEARED TO FALL THROUGH THE SCREW HOLE IN THE CUP. A SECOND SCREW WAS USED AND SEEMED TO DO THE SAME THING HOWEVER IT APPEARED STABLE ENOUGH AND REMAINS IMPLANTED. 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 17670497 ↗
• MalfunctionAug 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT UPON INITIAL IMPACTION, A RING APPEARED ON XRAY. WHEN SURGEON EXAMINED CUP, THE RIM OF THE CUP HAD FRACTURE OFF THE REMAINDER OF THE IMPLANT. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17637743 ↗
• MalfunctionJun 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED, THAT A TRILOGY SCREW HAS GONE ALL THE WAY THROUGH THE OSSEOTI CUP. 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 17165147 ↗
• MalfunctionMay 19, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE G7 CUP WAS COLD WELDED TO THE STRAIGHT G7 IMPACTOR AND COULD NOT BE REMOVED INTRAOPERATIVELY. THE SURGERY WAS DELAYED BY 20 MINUTES, HOWEVER, COMPLETED USING A CURVED IMPACTOR AND A 56MM SHELL. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16960347 ↗
• MalfunctionMay 3, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGING APPEARED TO NOT BE GLUED CORRECTLY CLOSE TO THE CORNER, AND THE SURGEON REQUESTED ANOTHER IMPLANT. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT IMPACT, AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860545 ↗
• MalfunctionFeb 7, 2023Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313721 ↗
• MalfunctionMar 30, 2022Positioning Failure; Inadequacy of Device Shape and/or Size; Positioning Failure; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THE SIZE 54 G7 OSSEOTI SHELL WAS VERY LOOSE. THE IMPLANT WAS INSERTED IN THE PATIENT AND THEN REMOVED. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13952107 ↗