Avenir Complete™ 574101060Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024508668), received between Feb 10, 2023 and Feb 11, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).
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
- Adverse Event Without Identified Device or Use Problem3
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration1
Patient problems
- Bone Fracture(s)3
- Pain2
- Ambulation or Postural Difficulties1
- Periprosthetic fracture1
- Seroma1
- Wound Dehiscence1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Periprosthetic fracture
MAUDE report 24313470 ↗InjuryApr 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. APPROXIMATELY TWO (2) WEEKS POST-IMPLANTATION, THE PATIENT EXPERIENCED A TWISTING MOTION OF THE LEFT LEG WHICH RESULTED IN SEVERE PAIN AND AN INABILITY TO WALK. DIAGNOSTIC IMAGES REVEALED A PERIPROSTHETIC TROCHANTERIC FRACTURE AND SUBSIDENCE OF THE FEMORAL STEM. SUBSEQUENTLY, THE PATIENT UNDERWENT AN UNCOMPLICATED FRACTURE REDUCTION PROCEDURE WITH REVISION OF THE FEMORAL HEAD AND STEM COMPONENTS. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.
Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Pain; Seroma; Wound Dehiscence
MAUDE report 19095635 ↗InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A WEEK POST IMPLANTATION IT WAS FOUND THAT THE IMPLANT HAD COLLAPSED 0.5 CM MORE THAN THE FINAL BROACH. THE INTRA OP X-RAY DID NOT SHOW ANYTHING BECAUSE THE PATIENT WAS IN SO MUCH PAIN FOR A FEW DAYS POST IMPLANTATION SO A CT SCAN WAS TAKEN AND SHOWED A FRACTURE OF THE FEMUR. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s); Pain
MAUDE report 18623447 ↗InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Bone Fracture(s)
MAUDE report 16351957 ↗
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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