Metha® NC088KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963183745), received between Mar 16, 2021 and Aug 19, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Biocompatibility” (2 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED TO AESCULAP AG THAT A METHA® SHORT HIP SYSTEM (PART # NC088K) WAS IMPLANTED DURING A PROCEDURE PERFORMED APPROXIMATELY 13 YEARS AND 4 MONTHS AGO. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED A LARGE OSTEOLYSIS OF THE LEFT PELVIS WITH STABLE CUP. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE MODULAR METHASHAFT WAS DISCOLOURED BLACK AT THE CONE CONNECTION. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER (B)(4) REFERENCE XC (B)(4). INVOLVED COMPONENTS : NC085T - METHA SHORT HIP STEM CAP SIZE 5 - LOT 51414643. NK560 - BIOLOX PROSTHESIS HEAD 12/14 32MM S - LOT UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 12343276 ↗
• InjuryMar 16, 2021Biocompatibility; Biocompatibility

  ASSOCIATED MEDWATCH: 9610612-2021-00170 ((B)(4)+ NC081T). INVOLVED COMPONENTS: NH050T - PLASMACUP SC SIZE 50MM - 51484353; NH202 - SC/MSC PE-INSERT 32MM 48/50 SYM. - 51953832; AE-QAS-COMPET-IMP - COLLECT.NO.QAS IMPLANTS FROM COMPETITORS - UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 11495657 ↗