G7® Vivacit-E® 30123605Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of G7 Vivacit-E (41)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00889024520486), received between Oct 21, 2021 and Sep 29, 2026 — classified as 4 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (7 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert7
- Device Contaminated During Manufacture or Shipping2
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Noise, Audible1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Failure of Implant1
- Joint Dislocation1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Detachment of Device or Device Component; Noise, Audible
Patient problems: Failure of Implant
MAUDE report 50926993 ↗InjuryJul 1, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 25677373 ↗MalfunctionFeb 20, 2026Difficult to Insert
IT WAS REPORTED THAT AFTER INSERTING THE LINER IMPLANT, IT CAME LOOSE FROM THE SHELL DURING THE TRIAL REDUCTION. AFTER REPEATEDLY TAPPING IT, IT WAS REINSERTED. 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 24400541 ↗MalfunctionJul 3, 2025Difficult to Insert; Difficult to Insert
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22397115 ↗MalfunctionApr 13, 2023Difficult 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 16733544 ↗MalfunctionApr 6, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16691276 ↗MalfunctionJul 27, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE LINER COULD NOT LOCK INTO THE SHELL IN THE SURGICAL FIELD. THE SURGEON COMMENTED THAT THE PROCEDURE WAS DONE CORRECTLY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15111718 ↗MalfunctionMay 12, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE SURGEON HAS TROUBLE GETTING THE LINER TO INSERT INTO THE CUP. AFTER SEVERAL HITS, THE SURGERY WAS FINALLY ABLE TO GET THE LINER IN AND COMPLETED THE SURGERY AS INTENDED. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT. 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 14374993 ↗InjuryMay 11, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT TWO SEPARATE LINERS WERE ATTEMPTED TO BE SEATED INTO THE CUP WITHOUT SUCCESS. NO ADVERSE CONSEQUENCES WERE REPORTED. 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 14361124 ↗MalfunctionMay 11, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT TWO SEPARATE LINERS WERE ATTEMPTED TO BE SEATED INTO THE CUP WITHOUT SUCCESS. NO ADVERSE CONSEQUENCES WERE REPORTED. 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 14360995 ↗InjuryOct 21, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED DURING A HIP PROCEDURE, WHEN OPENING THE LINER, A BIG BLACK HAIR WAS FOUND ON THE IMPLANT. SURGEON USED A NEW LINER. 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 12672328 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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