Avenir Complete™ 574202050Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Avenir Complete (37)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024509177), received between Mar 11, 2024 and Jul 23, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Implant subsidence” (1 report).
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
- Adverse Event Without Identified Device or Use Problem2
- Implant subsidence1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Hematoma1
- Low Blood Pressure/ Hypotension1
- No Clinical Signs, Symptoms or Conditions1
- Periprosthetic fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Implant subsidence; Adverse Event Without Identified Device or Use Problem; Implant subsidence
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO STEM SUBSIDENCE THAT PROGRESSED TO A FRACTURE AROUND THE PROSTHESIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Periprosthetic fracture
MAUDE report 22575570 ↗MalfunctionMay 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC HAD CRACK ON THE PACKAGING. IT WAS DETERMINED THAT STERILITY HAD BEEN BREACHED DUE TO THE OUTER CAVITY OF THE PACKAGING BEING CRACKED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22107632 ↗InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY COMPLETED. SUBSEQUENTLY, PRIOR TO OUTPATIENT DISCHARGE, POST-OPERATIVE ORTHOSTATIC HYPOTENSION AND A RIGHT POSTEROLATERAL HEMATOMA WERE NOTED. THE PATIENT WAS TRANSFERRED FROM THE SURGERY CENTER AND ADMITTED TO A HOSPITAL FACILITY FOR OBSERVATION AND MEDICAL INTERVENTION. SYMPTOMS RESOLVED AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. THE STUDY HAS SINCE BEEN COMPLETED PER PROTOCOL WITH NO FURTHER COMPLICATIONS OR ALLEGATIONS AGAINST THE DEVICE, ALL INITIAL PRODUCT REMAINS IMPLANTED. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.
Patient problems: Hematoma; Low Blood Pressure/ Hypotension
MAUDE report 18877594 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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.
How reports and recalls are matched · Editorial policy · Report an error on this page