Affixus® Natural Nail® 47-2486-056-40Recalls & 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
- 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 00889024505520), received between Jan 3, 2020 and Apr 28, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (4 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
- Migration4
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant1
- Insufficient Information1
- Loss of Range of Motion1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL PROCEDURE WITH THE AFFIXUS HUMERAL NAIL, AFTER WHICH, PRESENTS LIMITED MOVEMENT DUE TO LOOSENING OF TWO SCREWS. PATIENT IS PENDING FOR SCREW REMOVAL ON UNKNOWN DATE. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Loss of Range of Motion
MAUDE report 21920446 ↗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 15014073 ↗InjuryJul 26, 2021Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Insufficient Information; Pain
MAUDE report 12223779 ↗InjuryJan 3, 2020Migration; Migration
PATIENT WAS IMPLANTED ON THE LEFT SIDE AND A REVISION SURGERY IS YET TO TAKE PLACE FOR THE MIGRATION OF THE IMPLANT.
Patient problems: No Code Available
MAUDE report 9542482 ↗
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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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