G7® Vivacit-E® 30103205Recalls & 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
- 9
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024519855), received between Jun 28, 2021 and Jun 24, 2026 — classified as 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (6 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 Insert6
- Adverse Event Without Identified Device or Use Problem1
- Device Contaminated During Manufacture or Shipping1
- Device Dislodged or Dislocated1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Bursitis1
- Joint Laxity1
- Pain1
- Subluxation1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INSTABILITY AND SUBLUXATION OF THE JOINT FOLLOWING A FALL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Laxity; Subluxation
MAUDE report 25606638 ↗MalfunctionDec 4, 2025Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT A FOREIGN SUBSTANCE WAS ADHERING TO THE IMPLANT SURFACE. A SECOND IMPLANT WAS OPENED TO COMPLETE THE CASE WITHOUT DELAY, OR HARM. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715965 ↗InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY. APPROXIMATELY 2 YEARS LATER THE PATIENT RECEIVED A CORTISONE INJECTION TO THE RIGHT HIP FOR BURSITIS AND REPORTED AS RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bursitis; Pain
MAUDE report 20846394 ↗MalfunctionOct 17, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE TWO LINERS COULD NOT BE INSERTED CORRECTLY INTO THE SHELL DURING THE SAME CASE. ANOTHER LINER WAS USED TO COMPLETE THE CASE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17948418 ↗MalfunctionOct 17, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE TWO LINERS COULD NOT BE INSERTED CORRECTLY INTO THE SHELL DURING THE SAME CASE. ANOTHER LINER WAS USED TO COMPLETE THE CASE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17948415 ↗MalfunctionOct 16, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON WAS NOT ABLE TO ASSEMBLE THE LINELINER WITH THE SHELL. ANOTHER LINER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17941131 ↗MalfunctionSep 7, 2023Difficult to Insert; Difficult to Insert
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER 1822565 ZIMMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17699915 ↗MalfunctionAug 24, 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 12358669 ↗MalfunctionJun 28, 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 12075981 ↗
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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