Avenir® 01.06010.001 (UDI 00889024479456)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024479456), received between Nov 7, 2018 and Sep 17, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 31, 2018Class IITerminated

   Mislabeled Labeled Avenir Mller Stem size 1, the stem inside the packaging is an Avenir Mller Stem size 2 .

   Z-0644-2019 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS NOW REPORTED FROM THE CLINIC THAT THERE WAS NO SUITABLE CEMENTLESS SHAFT SIZE. SIZE 1 WAS TOO SMALL, SIZE 2 WAS TOO BIG. FOR THIS PATIENT A SIZE OF 1.5 WOULD BE SUITABLE, BUT THIS SIZE DOES NOT EXIST. THE SURGERY WAS FINISHED AFTER THE IMPLANTATION OF THE CEMENTED AVENIR STEM ¿ SIZE 2. IT WAS THEREFORE REPORTED THAT THERE WAS NO MALFUNCTION OF A ZIMMER BIOMET PRODUCT. THE PRODUCT (AVENIR STEM CEMENTED ¿ SIZE 2) HAS BEEN IMPLANTED ACCORDING TO SURGICAL TECHNIQUE. SINCE THIS EVENT DOES NOT REPRESENT AN ISSUE REGARDING THE PRODUCT BUT RATHER AN ISSUE REGARDING THE PRODUCT-PORTFOLIO, THIS CASE DOES NOT FULFILL THE CRITERIA OF A COMPLAINT ANYMORE. THIS CASE WILL BE INVALIDATED.

  Patient problems: No Code Available

  MAUDE report 9074342 ↗
• InjurySep 17, 2019No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Hip Fracture; No Information

  MAUDE report 9074327 ↗
• InjuryAug 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL STUDY REPORTED THAT 5 YEAR AFTER IMPLANTATION PATIENT REPORTED MODERATE PAIN, DISCOMFORT, MARKEDLY SLOWER AND ALTERED GAIT MOVEMENT. THE PRODUCT IS STILL IMPLANTED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 8919649 ↗
• MalfunctionNov 7, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NO EVENT UPDATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8045428 ↗