Affixus® Natural Nail® 47-2486-042-40Recalls & reported problems
Zimmer GmbH · Class 2 · Implant
All models of Affixus Natural Nail (55)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zimmer Affixus Natural Nail is used to fix broken bones, including shoulder fractures. The 52 reports mostly describe the implant shifting or backing out of position after surgery, sometimes with pain, and 46 reports mention an injury. There are no deaths and no recalls name this device. Report numbers have dropped in the past 12 months, with none filed since 2020 in that window compared with 2 before it.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 46
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00889024505452), received between Jan 3, 2020 and Oct 31, 2025 — classified as 46 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Migration” (40 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration40
- Migration or Expulsion of Device18
- Patient Device Interaction Problem9
- Adverse Event Without Identified Device or Use Problem2
- Loosening of Implant Not Related to Bone-Ingrowth2
- Expulsion1
- Mechanical Problem1
Patient problems
- Failure of Implant25
- Insufficient Information21
- No Clinical Signs, Symptoms or Conditions13
- Pain13
- No Code Available3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Implant Pain1
- Necrosis1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2025Migration; Migration
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23437335 ↗InjuryDec 26, 2024Migration; Migration
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 21021127 ↗InjuryJan 30, 2024Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 18606737 ↗InjuryJun 30, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 17236033 ↗InjuryJun 23, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17189713 ↗InjuryJun 23, 2023Migration; Migration
IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE AND AFTER APPROXIMATELY (6) WEEKS FROM THE INITIAL, THE SURGEON FOUND THAT THE PROXIMAL SCREW BACKED OUT FROM THE PROPER POSITION. PATIENT IS UNDER HEALTH PROFESSIONAL'S OBSERVATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17189593 ↗InjuryJun 22, 2023Migration; Migration
IT WAS REPORTED THAT FOUR (4) WEEKS AFTER IMPLANTATION OF SHOULDER NAIL, ONE OF THE PROXIMAL SCREWS HAS BACKED OUT FROM PROPER POSITION. IT IS NOT KNOWN WHICH ONE EXACTLY BACKED OUT. NO REVISION IS PLANNED SO FAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 17179749 ↗InjuryJun 13, 2023Migration; Migration
IT WAS REPORTED THAT AFTER TWO WEEKS AFTER THE INITIAL SURGERY, TWO PROXIMAL SCREWS BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL MONITOR THE PATIENT'S CONDITION. NO REVISION HAS BEEN PLANNED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 17115994 ↗InjuryJun 13, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 17115410 ↗InjuryJun 7, 2023Migration; Migration
IT WAS REPORTED THAT DURING THE INITIAL SURGERY, THE PATIENT WAS IMPLANTED WITH ANN NAIL. 6 WEEKS AFTER THE SURGERY ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION AND THE PATIENT EXPERIENCED PAIN. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE SCREW. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Failure of Implant; Pain
MAUDE report 17076876 ↗InjuryJun 6, 2023Migration; Migration
IT WAS REPORTED THAT DURING THE INITIAL SURGERY, THE PATIENT WAS IMPLANTED WITH ANN NAIL. 6 WEEKS AFTER THE SURGERY ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION AND THE PATIENT EXPERIENCED PAIN. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE SCREW. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Failure of Implant; Pain
MAUDE report 17071355 ↗InjuryApr 27, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT TWO (2) WEEKS AFTER INITIAL SURGERY, THE SURGEON FOUND ONE OF THE PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. REVISION SURGERY IS NOT PLANNED, AND THE PATIENT'S CONDITION WILL CONTINUE TO BE MONITORED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Failure of Implant
MAUDE report 16822308 ↗InjuryApr 26, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16813097 ↗InjuryApr 25, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 16805463 ↗InjuryApr 25, 2023Migration; Migration
IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL SURGERY AND APPROXIMATELY AFTER 6 WEEK THE SURGEON FOUND THAT THE PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND A REVISION SURGERY WAS PERFORMED TO REMOVE THESE SCREWS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Failure of Implant; Pain
MAUDE report 16805462 ↗InjuryApr 25, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16804861 ↗InjuryApr 3, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16662972 ↗InjuryJan 9, 2023Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE HIP DUE TO MIGRATION, APPROXIMATELY ONE (1) MONTH POST-OP. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Failure of Implant
MAUDE report 16120004 ↗InjuryDec 20, 2022Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY TWO (2) MONTHS AFTER IMPLANTATION, DURING A ROUTINE POST-OPERATIVE CHECKUP, IT WAS FOUND OUT THAT THE LEG SCREW HAD BACKED OUT FROM THE PROPER POSITION. 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 16012194 ↗InjurySep 26, 2022Migration; Migration
IT WAS REPORTED THAT 9 MONTHS AFTER INITIAL OP, A PROXIMAL SCREW WAS FOUND TO BE BACKED OUT FROM THE PROPER POSITION. PATIENT UNDERWENT. REVISION SURGERY WHERE ONLY THE MIGRATED SCREW WAS EXPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED YET.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 15483816 ↗InjurySep 5, 2022Expulsion; Expulsion
IT WAS REPORTED THAT 6 WEEKS AFTER IMPLANTATION, PATIENT EXPERIENCED HUMERAL HEAD NECROSIS. PROXIMAL SCREW NEXT TO THE SCREW HOLE HAD MIGRATED. REVISION SURGERY HAS BEEN PERFORMED ON AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Necrosis
MAUDE report 15354789 ↗InjuryAug 4, 2022Migration; Migration
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ANN NAIL. AFTER 2 MONTHS FROM THE INITIAL SURGERY, THE SURGEON FOUND 2 PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 15161935 ↗InjuryJul 14, 2022Migration; Migration
IT WAS REPORTED THAT THE SURGEON FOUND THAT THE PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION 1 MONTH AFTER THE INITIAL SURGERY. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT'S CONDITION. REVISION SURGERY IS NOT CURRENTLY PLANNED. NO FURTHER PATIENT OUTCOME WAS PROVIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED YET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15014034 ↗InjuryMay 19, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED, THAT: OPERATION WAS PERFORMED WITH ANN NAIL. AFTER 5 MONTHS FROM THE INITIAL, SURGEON FOUND ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEP AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14445941 ↗InjuryMay 18, 2022Migration; Migration
IT WAS REPORTED THAT ONE OF THE PROXIMAL SCREWS BACKED OUT FROM THE PROPER POSITION ONE WEEK AFTER INITIAL IMPLANTATION. THE SURGEON IS KEEPING AN EYE ON THE PATIENT'S CONDITION. NO REVISION SURGERY PLANNED SO FAR. NO HARM REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 14433108 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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