Avenir® Müller 01.06010.201Recalls & reported problems
Zimmer GmbH · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024590731), received between Nov 5, 2024 and Nov 5, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
- Separation Problem1
Patient problems
- Failure of Implant1
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Separation Problem; Loosening of Implant Not Related to Bone-Ingrowth; Separation Problem
IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 21 DAYS POST IMPLANTATION DUE TO A DISLOCATION CAUSED BY A FALL IN THE DOMESTIC ENVIRONMENT. DURING THE INTRAOPERATIVE ATTEMPT TO DETACH THE HEAD FROM THE STEM, THE HEAD AND STEM CAME OUT OF THE MEDULLARY CAVITY OF THE FEMUR AFTER THE THIRD STROKE. AS A RESULT, THE MEDULLARY CANAL HAD TO BE PARTIALLY FREED FROM THE CEMENT IN ORDER TO BE ABLE TO PLACE A NEW STEM INCLUDING A NEW THIN CEMENT MANTLE AND A HEAD WITH MORE OFFSET HAD TO BE IMPLANTED. DELAY 60 MINUTES FOR COMPLEX PARTIAL REMOVAL OF THE CEMENT IN THE FEMUR TO MAKE ROOM FOR RE-IMPLANTATION AND PARTIAL NEW CEMENT MANTLE, TRIAL REDUCTION, RE-IMPLANTATION INCLUDING HARDENING OF THE CEMENT, REDUCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 20612029 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
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- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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