AvenirRecalls & reported problems across all models

We found 24 models of Avenir by Zimmer GmbH in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Nov 7, 2018 and Apr 28, 2026 — classified as 49 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (11 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Avenir recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 31, 2018Terminated

   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 Avenir problems

Avenir models

24 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Avenir® 01.06010.001

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 recall4 reports
• Avenir® 01.06010.003

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  5 reports
• Avenir® 01.06010.004

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  5 reports
• Avenir® 01.06010.105

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  5 reports
• Avenir® 01.06010.002

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  4 reports
• Avenir® 01.06010.004

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  3 reports
• Avenir® 01.06010.005

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  3 reports
• Avenir® 01.06010.107

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  3 reports
• Avenir® 01.06010.003

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  2 reports
• Avenir® 01.06010.105

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  2 reports
• Avenir® 01.06010.107

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• Avenir® 01.06010.007

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  2 reports
• Avenir® 01.06010.001

  Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
  2 reports
• Avenir® 01.06010.103

  Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
  2 reports
• Avenir® 01.06010.104

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  2 reports
• Avenir® 01.06010.005

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• Avenir® 01.06010.008

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  2 reports
• Avenir® 01.06620.004

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• Avenir® 01.06010.002

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 report
• Avenir® 01.06010.301

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 report
• Avenir® 01.06010.303

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 report
• Avenir® 01.06010.101

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• Avenir® 01.06010.006

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• Avenir® 01.06010.106

  Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
  1 report

Recent Avenir adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Difficult to Insert; Peeled/Delaminated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY TOTAL HIP ARTHROPLASTY. DURING THE PROCEDURE, THE SURGERY ATTEMPTED TO FURTHER ADVANCE THE FEMORAL STEM TO CORRECT EXCESSIVE LEG LENGTHENING WHICH RESULTED IN A FISSURE OF THE FEMORAL SHAFT. THE STEM WAS REMOVED, AND CERCLAGE CABLES WERE PLACED AROUND THE SHAFT. UPON INSPECTION OF THE EXPLANTED STEM, THE SURGEON NOTED DAMAGE TO THE STEM COATING; THEREFORE, A NEW STEM OF THE SAME SIZE WAS USED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 25021654 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Extraskeletal ossification

  MAUDE report 24007752 ↗
• InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION 2 YEARS POST IMPLANTATION DUE TO STEM LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Aseptic loosening

  MAUDE report 23074491 ↗
• InjuryApr 3, 2025Implant subsidence; Implant subsidence

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 21762556 ↗
• InjuryMar 13, 2025Adverse 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 21595269 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. THE PATIENT HAS HAD PAIN, DISCOMFORT, AMBULATION DIFFICULTIES, INSTABILITY, LEG LENGTH DISCREPANCY, DIFFICULTY WITH GETTING IN AND OUT OF VEHICLE, AND FEAR OF METAL TOXICITY SINCE INITIAL SURGERY. NO TREATMENT HAS BEEN REPORTED, AND ALL COMPONENTS REMAIN IMPLANTED. PATIENT WILL FOLLOW-UP WITH A NEW SURGEON APPROXIMATELY 9 MONTHS POST-IMPLANTATION. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain; Unequal Limb Length

  MAUDE report 21548640 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT ALLEGES PAIN IN HIP AND SEVERE ANAPHYLAXIS. IT IS UNKNOWN IF REVISION SURGERY IS PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 21375106 ↗
• 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 ↗
• InjuryNov 13, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION SURGERY APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO THE STEM IMPINGING ON THE CUP. THE STEM REMAINED IMPLANT. HEAD, LINER AND SHELL REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 20674495 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS A REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Bone Fracture(s)

  MAUDE report 17849907 ↗
• InjuryAug 1, 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: Bone Fracture(s)

  MAUDE report 17434285 ↗
• 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 ↗
• InjuryJul 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIP PROSTHESES IMPLANTATION APPROXIMATELY NINE (9) YEARS AGO. ABOUT SEVEN (7) YEARS LATER PATIENT HAD A DOMESTIC 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 17341423 ↗
• InjuryJul 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIP PROSTHESES IMPLANTATION APPROXIMATELY FOUR AND HALF (4,5) YEARS AGO. ABOUT THREE AND HALF (3,5) YEARS LATER PATIENT HAD A DOMESTIC 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 17341279 ↗

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