Biolox® forte NK461Recalls & reported problems
Aesculap AG · BIOLOX PROSTHESIS HEAD 12/14 28MM M · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653119882), received between Mar 18, 2021 and Mar 18, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Disintegration” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Disintegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2021Material Disintegration; Material Disintegration
IT WAS REPORTED TO AESCULAP AG THAT A BIOLOX PROSTHESIS HEAD 12/14 28MM (PART # NK461) WAS IMPLANTED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2002. ACCORDING TO THE COMPLAINANT, EIGHTEEN (18) YEARS POST SURGERY, THE CERAMIC HEAD WAS DAMAGED. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE COMPLAINT DEVICE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NK712T BICONTACT SD PLASMAPORE 12/14 SIZE 12MM - LOT UNKNOWN. NH048T. PLASMACUP SC SIZE 48MM. LOT UNKNOWN. NH092 SC/MSC CERAMICS INSERT 28MM 48/50 SYM. LOT UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11520498 ↗
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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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