Avenir® Müller 01.06010.102Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024288140), received between Sep 25, 2023 and Sep 25, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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.

Most reported problems

Recent adverse event reports

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

• InjurySep 25, 2023Fracture; Fracture

  NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 17806504 ↗

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