G7 ACETABULAR SCREW 010000996Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00880304527447), received between Aug 27, 2020 and Nov 14, 2025 — classified as 4 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping4
- Adverse Event Without Identified Device or Use Problem2
- Loosening of Implant Not Related to Bone-Ingrowth2
- Packaging Problem2
- Delivered as Unsterile Product1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement3
- Bone Fracture(s)2
- Failure of Implant2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s)
MAUDE report 23554852 ↗InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY FIVE DAYS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A FRACTURE. PATIENT HAD A PROXIMAL FEMUR REPLACEMENT AND PELVIC FIXATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s)
MAUDE report 20397683 ↗MalfunctionJun 10, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT BEFORE BEING OPENED TO THE STERILE FIELD, THE BOX FOR THE SCREW WAS OPENED; IT WAS NOTICED THAT THERE WERE PIN HOLE MARKS IN THE STERILE PACKAGING. THE SCREW WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19499782 ↗InjuryMay 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY THREE DAYS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO CUP LOOSENING. THE CUP, SCREWS, LINER, BEARING, AND HEAD WERE REVISED. THE STEM WAS RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 19386902 ↗InjuryMay 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY THREE DAYS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO CUP LOOSENING. THE CUP, SCREWS, LINER, BEARING, AND HEAD WERE REVISED. THE STEM WAS RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 19386865 ↗MalfunctionAug 23, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCTS WERE FOUND TO BE NONCONFORMING. DURING INCOMING INSPECTION, A TEAM MEMBER FOUND DEBRIS IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. 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 15274748 ↗MalfunctionOct 5, 2021Packaging Problem; Packaging Problem
IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCTS WERE FOUND TO BE NONCONFORMING. DURING INCOMING INSPECTION, THE TEAM MEMBER FOUND THE SEAL WIDTH WAS LESS THAN 1/4 INCH (6.35MM). NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12575656 ↗MalfunctionFeb 18, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 11343094 ↗MalfunctionDec 8, 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 Known Impact Or Consequence To Patient
MAUDE report 10968360 ↗MalfunctionDec 8, 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 10968312 ↗MalfunctionAug 27, 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 10460679 ↗
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, ClassifiedG7 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 · TerminatedG7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
- Z-1838-2014 · May 7, 2014 · TerminatedG7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
Other Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented devices
- DJO SURGICAL 942-01-40HEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented2 recalls23 reports
- Vivacit-E® 110031012Zimmer, Inc. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall33 reports
- G7® Dual Mobility Acetabular System 110024462Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall22 reports
- DJO SURGICAL 942-01-36HEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall5 reports
- DJO SURGICAL 942-01-36JEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall1 report
- DJO SURGICAL 942-01-32CEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall0 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145150Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented46 reports
- TAPERLOC COMPLETE MICRO PRIMARY FEMORAL 51-106160Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented35 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.