Avenir® 01.06010.107 (UDI 00889024591042)Recalls & reported problems
Zimmer GmbH · Class 2 · Implant
All models of Avenir (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024591042), received between Jul 18, 2023 and Sep 17, 2025 — classified as 3 injuries.
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
- Implant subsidence1
- Loss of Osseointegration1
- Patient Device Interaction Problem1
Patient problems
- Aseptic loosening1
- Bone Fracture(s)1
- Failure of Implant1
- Fall1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION 2 YEARS POST IMPLANTATION DUE TO STEM LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Aseptic loosening
MAUDE report 23074491 ↗InjuryApr 3, 2025Implant subsidence; Implant subsidence
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21762556 ↗InjuryJul 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT HIP PROSTHESES IMPLANTATION APPROXIMATELY EIGHT AND HALF (8,5) YEARS AGO. ABOUT ONE (1) YEAR LATER PATIENT HAD A DOMESTIC FALL AND SUSTAINED A B2 PERIPROSTHETIC FRACTURE. THE PATIENT UNDERWENT REVISION OF THE FEMORAL COMPONENT. THERE WAS MINIMAL BONE INGROWTH ON THE REMOVED STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s); Fall
MAUDE report 17341275 ↗
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- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
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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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