Avenir® 01.06010.103Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024590960), received between Aug 24, 2020 and Aug 4, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Crack” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Crack1
- Fracture1
- Patient Device Interaction Problem1
Patient problems
- Bone Fracture(s)1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2021Crack; Fracture; Patient Device Interaction Problem; Patient Device Interaction Problem
DURING AN INITIAL SURGERY, THE FEMUR FRACTURED WHILE IMPLANTING THE DEVICE. THERE WAS A PERIPROSTHETIC CALCAR CRACK, WHICH WAS TREATED WITH A FEMUR CABLE. THE PATIENT HAS NO COMPLAINTS POST THE INITIAL SURGERY. THE PATIENT INVOLVED IN THE EVENT WAS A PART OF THE FOLLOWING STUDY: PROSPECTIVE MULTICENTER LONGITUDINAL COHORT STUDY INCLUDING AN INTERVENTIONAL (SOC) RCT SUB-STUDY.
Patient problems: Bone Fracture(s)
MAUDE report 12275271 ↗InjuryAug 24, 2020Appropriate Device Problem Term/Code Not Available
PATIENT WAS IMPLANTED ON THE UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10441412 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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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