Avenir® 01.06010.004 (UDI 00889024590977)Recalls & reported problems
Zimmer GmbH · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024590977), received between Dec 29, 2020 and Jan 9, 2025 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem2
- Adverse Event Without Identified Device or Use Problem1
- Biocompatibility1
- Insufficient Device Problem Information1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Bone Fracture(s)1
- Discomfort1
- Insufficient Information1
- Pain1
- Periprosthetic fracture1
- Unequal Limb Length1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s); Periprosthetic fracture
MAUDE report 21114644 ↗MalfunctionMar 13, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16529414 ↗InjuryAug 13, 2021Insufficient Device Problem Information
NOTE: IN ONE OF THE FOLLOW-UP RESPONSES IN THE COMPLAINT, IT WAS STATED THAT THE LEFT HIP CAUSED THE PAIN AND LIMPING, NOT THE RIGHT HIP (WHICH IS WHERE ZB DEVICES ARE IMPLANTED). BECAUSE OF THIS, IT IS NOW CLEAR THAT THE COMPLAINED PRODUCTS ARE NOT ZIMMER BIOMET PRODUCTS. THEREFORE, PLEASE DELETE THIS REPORT FROM YOUR SYSTEM: (B)(4) / MFR: 0009613350-2021-00403-1.
Patient problems: Pain
MAUDE report 12317959 ↗MalfunctionJan 12, 2021Mechanical Jam; Mechanical Jam
DURING THE SURGERY THE HEAD COULD NOT BE DETACHED FROM THE SHAFT. IT IS NOT KNOWN IF THERE WAS A DELAY IN SURGERY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11154726 ↗InjuryDec 29, 2020Biocompatibility; Activation, Positioning or Separation Problem; Biocompatibility; Activation, Positioning or Separation Problem
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions; Unequal Limb Length
MAUDE report 11088122 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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