Avenir Complete® 574999040Recalls & reported problems
Zimmer, Inc. · Class 2
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024510142), received between Nov 22, 2023 and Apr 22, 2026 — classified as 1 injury, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (11 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
- Fracture11
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2026Fracture
IT WAS REPORTED THAT THE PIVOT OF THE RASP OF THE AVENIR COMPLETE STEM BORK WHILE PROPERLY STRIKING THE RASP HANDLE TO EXTRACT THE RASP FROM THE FEMORAL CANAL, LEAVING THE RASP INSIDE THE PATIENT UNTIL IT COULD BE REMOVED USING APPROPRIATE INSTRUMENTS. IT WAS NOTED THAT A DELAY OCCURRED, AND NO FOREIGN BODY WAS RETAINED IN THE PATIENT. THE CASE WAS COMPETED SUCCESSFULLY WITH NO OTHER REPORTED IMPACT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24952768 ↗MalfunctionSep 22, 2025Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23111433 ↗MalfunctionMay 23, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22077223 ↗MalfunctionMay 20, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE REMOVING THE BROACH, THE MALE JUNCTION FRACTURED OFF. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22052115 ↗MalfunctionApr 4, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF THE BROACH BROKE OFF. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21772783 ↗MalfunctionJan 13, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE REMOVING THE SIZE 4 BROACH, THE MALE JUNCTION FRACTURED OFF. THE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THE MALFUNCTION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21138409 ↗MalfunctionDec 31, 2024Fracture; Fracture
IT WAS REPORTED THAT THE NIPPLE OF SIZE 4 BROACH FRACTURED OFF WHILE IN THE BONE. THERE WAS NO FOREIGN RETAINED BODY IN PATIENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21048611 ↗MalfunctionNov 19, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20726061 ↗MalfunctionSep 24, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE BROACHING A PIECE OF THE BROACH BROKE OFF IN THE BROACH HANDLE. ALL PIECES WERE RETRIEVED. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20290129 ↗MalfunctionAug 6, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917060 ↗MalfunctionJan 25, 2024Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580302 ↗MalfunctionNov 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BROACH PIECE DROPPED OFF WHILE THE SURGEON WAS USING THE CALCAR PLANER. THERE WERE NO KNOWN CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18190539 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, uncemented devices
- LFIT 6260-9-136Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented166 reports
- Trident 623-00-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented112 reports
- Accolade 6021-0435Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented88 reports
- EXETER 0580-1-044Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 recall22 reports
- Endo-Model SL Knee Prosthesis System 16-2840/02WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall17 reports
- Endo-Model SL Knee Prosthesis System 16-2840/05WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall12 reports
- Trident 623-10-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented57 reports
- LFIT 6260-9-336Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented56 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.