G7® Vivacit-E® 30103606Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00889024519916), received between Mar 16, 2021 and Mar 16, 2026 — classified as 15 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THE STERILE PACKAGING OF A NEUTRAL LINER WAS DEFORMED/MELTED AND COULD NOT BE SAFELY OPENED, AND THE SURGEON ELECTED TO USE A HIGH WALL LINER. THERE WERE NO CONSEQUENCES OR IMPACTS TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604056 ↗
• InjuryDec 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 23711834 ↗
• MalfunctionJun 19, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER COULD NOT BE INSERTED CORRECTLY. THE SURGEON USED ANOTHER PRODUCT TO COMPLETE THE SURGERY. THERE WAS A 5 TO 10 MINUTE DELAY IN THE SURGERY, DUE TO REPLACING THE PRODUCT. THERE WAS NO IMPACT ON THE PATIENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. 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 22292155 ↗
• MalfunctionJun 2, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE LINER COULD NOT BE INSERTER CORRECTLY. ANOTHER LINER WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE WITH A 5-MINUTE DELAY. 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 22123822 ↗
• InjuryJun 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 22122971 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, AFTER THE FIRST YEAR, DEVELOPED CONTRALATERAL LEG SHORTENING AND BEGAN EXPERIENCING PAIN, A LIMP, AND PROBLEMS WALKING. THE PATIENT WAS PRESCRIBED PHYSICAL THERAPY, AND THE OUTCOME IS PENDING.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 21917722 ↗
• MalfunctionMar 21, 2025Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665473 ↗
• MalfunctionJan 13, 2025Delivered as Unsterile Product; Device Markings/Labelling Problem; Difficult to Open or Close; Delivered as Unsterile Product; Device Markings/Labelling Problem; Difficult to Open or Close

  IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED, IT WAS NOTICED THAT THE INTERNAL STERILE PACK AND EXTERNAL STERILE PACK WERE SEEMINGLY HEAT-SHRUNK. THE INNER PACKAGE WAS WELDED TO THE EXTERNAL PACKAGE. THE OUTSIDE OF THE BOX ALSO HAD BLURRED/SMEARED WRITING. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138184 ↗
• InjuryNov 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION PROCEDURE 2 MONTHS POST IMPLANTATION DUE TO RECURRENT DISLOCATIONS WITH DISCOMFORT. DURING THE REVISION THE FEMORAL STEM AND ACETABULAR CUP WERE FOUND TO BE WELL INGROWN AND WELL POSITIONED. THE HEAD AND LINER WERE REVISED WITHOUT COMPLICATIONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Discomfort; Joint Dislocation

  MAUDE report 20795207 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Bursitis; Pain

  MAUDE report 20744413 ↗
• MalfunctionNov 19, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727023 ↗
• MalfunctionOct 24, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20521269 ↗
• InjuryJul 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE AND A HALF YEARS POST IMPLANTATION OF A TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO UNEXPLAINED PAIN. THE MODULAR NECK, HEAD AND LINER WERE REPLACED. THERE WERE NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. SURGICAL TECHNIQUE WAS UTILIZED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 19867223 ↗
• MalfunctionJul 1, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THERE WAS CONTAMINANT IN THE PACKAGING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643803 ↗
• InjuryAug 3, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT AFTER THE IMPLANT WAS OPENED, A HAIR WAS FOUND DIRECTLY ON THE IMPLANT. THE SURGEON WAITED FOR ANOTHER LINER TO BE DELIVERED THAT SAME DAY. ONCE IT ARRIVED 20-25 MINS LATER, THE NEW ONE WAS IMPLANTED. THEY CONTINUED WITH THE OTHER STEPS OF THE PROCEDURE WHILE WAITING FOR THE NEW LINER TO SHOW UP. TOTAL WAIT TIME FOR THE PATIENT WAS 10 MINUTES. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450908 ↗
• MalfunctionJul 21, 2023Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370303 ↗
• InjuryMay 11, 2023Unstable; Unstable

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Fall

  MAUDE report 16914859 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY 1 MONTH POST IMPLANTATION, THE PATIENT WAS DIAGNOSED WITH A LEFT POPLITEAL, DEEP VEIN THROMBOSIS. POST-OPERATIVELY, THE PATIENT WAS PRESCRIBED FRAGMIN AND REPORTS HAVING CALF TENSION, WITH MINIMAL ERYTHEMA, THREE DAYS POST-OPERATIVELY. IT WAS RESOLVED WITHOUT COMPLICATIONS AND ALL IMPLANTS REMAIN IN PLACE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Thromboembolism

  MAUDE report 15393849 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY PATIENT IS EXPERIENCING PAIN APPROXIMATELY 9 MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 15295614 ↗
• InjuryAug 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 1-MONTH POST IMPLANTATION DUE TO DISLOCATION AFTER A FALL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 15162954 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 14550541 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO INFECTION. THE HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bacterial Infection

  MAUDE report 14548597 ↗
• InjuryFeb 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Pain; Swelling/ Edema; Unequal Limb Length

  MAUDE report 13505334 ↗
• MalfunctionMar 22, 2021Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11542217 ↗
• MalfunctionMar 22, 2021Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11542215 ↗