Avenir® 01.06010.003 (UDI 00889024590953)Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024590953), received between Nov 3, 2020 and Jul 19, 2023 — classified as 5 injuries.
The most frequently reported specific device problem is “Patient Device Interaction 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Patient Device Interaction Problem2
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
Patient problems
- Bone Fracture(s)3
- Fall2
- Anemia1
- Blood Loss1
- Low Blood Pressure/ Hypotension1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT HIP PROSTHESES IMPLANTATION APPROXIMATELY SEVEN (7) YEARS AGO. ABOUT SIX AND HALF (6,5) YEARS LATER PATIENT HAD A LOW ENERGY FALL AND SUSTAINED A B2 PERIPROSTHETIC FRACTURE. THE PATIENT UNDERWENT REVISION OF THE FEMORAL COMPONENT. THERE WAS MINIMAL BONE INGROWTH ON THE REMOVED STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s); Fall
MAUDE report 17349072 ↗InjuryJul 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT HIP PROSTHESES IMPLANTATION APPROXIMATELY EIGHT (8) YEARS AGO. ABOUT SIX (6) YEARS LATER PATIENT HAD A LOW ENERGY FALL AND SUSTAINED A B2 PERIPROSTHETIC FRACTURE. THE PATIENT UNDERWENT REVISION OF THE FEMORAL COMPONENT. THERE WAS MINIMAL BONE INGROWTH ON THE REMOVED STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s); Fall
MAUDE report 17341709 ↗InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 16662206 ↗InjurySep 28, 2021Fracture; Appropriate Device Problem Term/Code Not Available
PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE. SUBSEQUENTLY THE PATIENT SUFFERED TRAUMATIC FALL AND PERIPROSTHETIC FRACTURE OF THE PROXIMAL FEMUR. THE PATIENT UNDERWENT A REVISION SURGERY.
Patient problems: Bone Fracture(s)
MAUDE report 12539519 ↗InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem
PATIENT WAS IMPLANTED ON THE LEFT SIDE. SUBSEQUENTLY PATIENT EXPERIENCED POST-OPERATIVE BLOOD LOSS AND HYPOTENSION REQUIRING MEDICAL INTERVENTION AND THEREBY PROLONGING HOSPITALIZATION.
Patient problems: Anemia; Blood Loss; Low Blood Pressure/ Hypotension
MAUDE report 10780096 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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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