Avenir® Müller 01.06010.005Recalls & reported problems

Zimmer GmbH · Avenir Müller stem 5 Standard · Class 2 · Implant

Data updated Oct 16, 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 00889024288089), received between Mar 10, 2026 and Mar 10, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K123392); they may or may not involve this specific model.

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

Aseptic loosening1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMar 10, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, UNDERWENT A REVISION OF ALL PRODUCTS 12 YEARS, 4 MONTHS POST PRIMARY SURGERY DUE TO LOOSENING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Aseptic loosening
MAUDE report 24557707 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123392. One submission often covers many models, so check the product and lot details in each record.

Z-0644-2019 · Oct 31, 2018 · Terminated
Avenir Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility thr
Z-1524-2018 · Feb 28, 2018 · Terminated
Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
Z-1525-2018 · Feb 28, 2018 · Terminated
Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
Z-2292-2016 · Jun 30, 2016 · Terminated
Avenir Mller Stem 4 Standard Avenir Mller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear

Device details

UDI-DI	`00889024288089`
Brand	Avenir® Müller
Model	01.06010.005
Company	Zimmer GmbH
Product code	KWY · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Class	Class 2
FDA submission	K123392
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 14, 2019

Device type (GMDN): Coated hip femur prosthesis, modular

A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices

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66 reports
RINGLOC BI-POLAR HIP SYSTEM 11-165228
Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
1 recall1 death12 reports
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Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
60 reports
TANDEM 71324046
Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
1 recall9 reports
TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170
Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
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All Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices →

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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