G7® Acetabular System 010000662Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00880304524217), received between Jul 14, 2020 and Sep 29, 2026 — classified as 16 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (K121874); they may or may not involve this specific model.

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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Open or Remove Packaging Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937181 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection

  MAUDE report 50762600 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  No further information is available at the time of this report.

  Patient problems: Abscess; Ambulation or Postural Difficulties; Bacterial Infection; Medical device site infection; Purulent Discharge; Scar Tissue; Sepsis; Septic Shock; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25184327 ↗
• MalfunctionApr 13, 2026Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL HIP ARTHROPLASTY, THE INLAY COULD NOT BE ANCHORED INTO THE SHELL AFTER MULTIPLE ATTEMPTS. SECONDARY IMPLANTS WERE USED TO COMPLETE THE PROCEDURE WITHOUT ADDITIONAL COMPLICATION. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866170 ↗
• InjuryNov 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT POSTOPERATIVE FINDINGS REVEALED THAT THE ACETABULAR SCREW HAD PASSED THROUGH THE SCREW HOLE OF THE ACETABULAR CUP. NO PLAN TO REMOVE THE SCREW. TWO PRODUCT LABELS WERE SUBMITTED; HOWEVER, THE SURGEON CANNOT CONFIRM WHICH SCREW IS THE COMPLAINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23534482 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Bursitis; Pain

  MAUDE report 23059166 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A MEDICAL BLOCKADE APPROXIMATELY THREE AND A HALF MONTHS POST IMPLANTATION DUE TO TROCHANTER BURSITIS, WHICH WAS POSSIBLY CAUSED BY A FALL. THE OUTCOME OF THE COMPLICATION WAS NOTED AS TOLERATED. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.

  Patient problems: Bursitis

  MAUDE report 22884490 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON REASSESSMENT OF THE REPORTED EVENT AND ADDITIONAL INFORMATION RECEIVED, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE TENDONITIS WAS UNRELATED TO THE DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Tendinopathy

  MAUDE report 22026353 ↗
• InjuryMay 1, 2025Malposition of Device; Noise, Audible; Malposition of Device; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED SEVEN (7) YEARS POST IMPLANTATION DUE TO MALPOSITION OF THE CUP AND THE TRUNNION OF THE STEM SITTING INFERIOR OF THE CUP. THE HEAD, CUP, AND LINER WERE EXPLANTED. THE PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCTS. DILIGENCE FOR ADDITIONAL INFORMATION IS ONGOING.

  Patient problems: Crepitus; Failure of Implant

  MAUDE report 21943899 ↗
• MalfunctionMar 5, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INSERT DIDN'T FIT THE ACETABULAR COMPONENT. THE PROCEDURE WAS DELAYED BY 60 MINUTES WITH THE PROCEDURE COMPLETED WITH ANOTHER DEVICE. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21524923 ↗
• MalfunctionMay 20, 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 19353749 ↗
• MalfunctionMar 25, 2024Separation Failure; Material Deformation; Separation Failure; Material Deformation

  IT WAS REPORTED ONE OF THE SCREW CAPS IN THE G7 PPS SHELL WERE STRONGLY TIGHTENED AND THE SCREWDRIVER STRIPPED THE CAP TRYING TO GET IT OUT OF THE SHELL. A NEW SHELL HAD TO BE OPENED TO COMPLETE THE CASE. THE SCREWDRIVER WAS FULLY ENGAGED AND IN GOOD WORKING CONDITION. THE SCREW CAPS ARE ALWAYS REMOVED BEFORE IMPLANTING IN THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970660 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS SEEN IN THE EMERGENCY ROOM APPROXIMATELY 14 MONTHS POST IMPLANTATION FOLLOWING A FALL DUE TO UNKNOWN REASONS. THE PATIENT WAS EXPERIENCING PAIN AND DIFFICULTY WITH MOBILITY. IMAGING DIAGNOSED A CONTUSION AND MEDICATION WAS GIVEN FOR PAIN MANAGEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Bruise/Contusion; Fall; Pain

  MAUDE report 18934874 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, WITH A HISTORY OF DYSPLASIA, WAS DIAGNOSED WITH MINIMAL GREATER TROCHANTER BURSITIS APPROXIMATELY FOUR YEARS POST IMPLANTATION. NOW, APPROXIMATELY NINE YEARS POST IMPLANTATION, THE PATIENT IS EXPERIENCING INTERMITTENT PAIN, SEVERE PAIN WITH WALKING AND AGGRAVATED PAIN WITH LIFTING LEG IN A STRAIGHT POSITION, WHILE LIFTING THE KNEE, LYING AND TWISTING. PAIN SUBSIDES WHILE SITTING AND HAS BEEN DIAGNOSED WITH PSOAS TENDINITIS. THE PATIENT IS BEING TREATED CONSERVATIVELY FOR THE TIME BEING AND NO FURTHER NOTES OF AN INCREASE IN PAIN HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Bursitis; Pain

  MAUDE report 18450888 ↗
• MalfunctionDec 6, 2023Difficult to Remove; Difficult to Remove

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18274188 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18259040 ↗
• InjuryMar 30, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Foreign Body In Patient; Osteolysis; Pain

  MAUDE report 16643144 ↗
• MalfunctionAug 23, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THE G7 STRAIGHT SHELL INSERTER AND G7 SHELL WOULD NOT DISENGAGE FROM EACH OTHER. AFTER FORCED REMOVAL, A LARGER SHELL WAS USED AND IMPLANTED. 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 15275870 ↗
• InjuryApr 1, 2022Positioning Failure; Malposition of Device; Positioning Failure; Malposition of Device

  IT WAS REPORTED THAT ON THE POSTOPERATIVE X-RAY OF AN INITIAL TOTAL HIP REPLACEMENT, IT WAS FOUND THAT THE SCREW WAS OUTSIDE OF THE CUP, AND THE CUP DID NOT SEEM TO BE FULLY ATTACHED TO THE ACETABULAR. FOLLOWED PROPER TECHNIQUE, USED TRILOGY SCREW, WITH G7 SPECIFIC GOLDEN DRILL GUIDE AND DRILL SHAFT. SAME DAY RE-OPENED AND REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13977386 ↗
• InjuryFeb 2, 2022Off-Label Use; Loosening of Implant Not Related to Bone-Ingrowth; Off-Label Use; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 13423895 ↗
• MalfunctionDec 9, 2021Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12969556 ↗
• MalfunctionApr 29, 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 11744541 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Confusion/ Disorientation; Convulsion/Seizure

  MAUDE report 11506812 ↗
• MalfunctionMar 1, 2021Device 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11393082 ↗
• MalfunctionFeb 10, 2021Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11307591 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121874. One submission often covers many models, so check the product and lot details in each record.

• Z-0007-2023 · Aug 25, 2022 · Open, Classified
  G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
• Z-1837-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
• Z-1838-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.