Metha® MONO NC292TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046963914233), received between Mar 7, 2021 and Oct 29, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED TO AESCULAP AG THAT A METHA ¿CAP 12/14 120°/0° SIZE 2 (PART # NC292T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE METHA IMPLANT NO. 2 WAS INSERTED INTO THE BONE, IT SANK DEEPER THAN THE POSITION WHERE IT COULD BE FIXED. THE IMPLANT WAS REMOVED, AND THEN THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER IMPLANT. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PATIENT HAD NO INFECTION AND NO HEALTH HAZARD WAS REPORTED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724483 ↗
• InjuryAug 24, 2021Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AG THAT A METHA CAP 12/14 120°/0° SIZE 2 (PART # NC292T) WAS USED DURING A SURGICAL PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, SEVEN (7) MONTHS AFTER THE SURGICAL PROCEDURE A FRACTURE OF CALCAR FEMORIS OCCURRED. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE COMPLAINT DEVICE HAS NOT YET BEEN 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).

  Patient problems: Failure of Implant

  MAUDE report 12363040 ↗
• InjuryMay 6, 2021Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AG THAT A METHA ¿CAP 12/14 120¿/0¿ SIZE 2 (PART # NC292T) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON. . ACCORDING TO THE COMPLAINANT, WHEN INSERTING THE STEM, A BONE FRACTURE OCCURRED IN THE NECK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER MANUFACTURERS DEVICE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11787732 ↗
• InjuryMar 7, 2021Crack; Crack

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NC292T - METHA ¿CAP 12/14 120°/0° SIZE 2. ACCORDING TO THE COMPLAINT DESCRIPTION, THE IMPLANT WAS DIFFICULT TO FIX. THA USING THE METHA STEM WAS CONDUCTED. DURING THE SURGERY, THE DOCTOR RASPED UP TO NUMBER 2 AND INSERTED THE REAL NUMBER 2. WHEN THE HEAD WAS INSERTED AFTER THE REDUCTION, THE DOCTOR FELT A SLIGHT DISCOMFORT. HE LOOKED CLOSELY AND FOUND A CRACK IN THE BACK OF HIS NECK. UPON CLOSE VISUAL INSPECTION, THE FRACTURE LINE EXTENDED TO THE FRONT OF THE LESSER TROCHANTER, AND THE PRODUCT WAS REMOVED. AFTER THAT, IT WAS REPLACED WITH THE BICONTACT STEM. HE CUT THE BONE AGAIN AND PROCEEDED WITH THE RASP. SINCE THERE WAS NO PROBLEM IN FIXING WITH BICONTACT, BICONTACT WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00141 (400502949 + NC292T), 9610612-2021-00142 (400502950 + NK560D).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426495 ↗