AS VEGA System® PS NX032ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963810184), received between Oct 14, 2022 and Oct 21, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NX032Z - AS VEGA PS FEMORAL COMP.CEMENTED F5R. ACCORDING TO THE COMPLAINT DESCRIPTION, THE VEGA DEVICES WERE REMOVED. THE ORIGINAL SURGERY WAS ABOUT FIVE (5) YEARS AGO. DURING REMOVAL, IT WAS NOTED THAT CEMENT NO LONGER ADHERED TO IMPLANTS NOR BONE; PICTURES WERE PROVIDED. REPLACEMENTS FOR THE IMPLANTS WERE MOST LIKELY NON-AESCULAP PRODUCTS. A REVISION WAS REQUIRED DUE TO LOOSENING. ADDITIONAL DETAILS HAVE BEEN REQUESTED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: (B)(4) (9610612-2022-00294) NX032Z, (B)(4) (9610612-2022-00295) AE-QAS-K521-56, (B)(4) (9610612-2022-00296) AE-QAS-K521-56.

  Patient problems: Failure of Implant

  MAUDE report 15655160 ↗
• InjuryOct 14, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS VEGA PS FEMORAL COMP. CEMENTED F5R (PART # NX032Z) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED APPROXIMATELY FIVE (5) YEARS AGO BY ANOTHER SURGEON. ACCORDING TO THE COMPLAINANT, POSTOPERATIVE LOOSENING OF THE IMPLANT OCCURRED. REPORTEDLY, THE CEMENT DID NOT ADHERE TO THE IMPLANTS OR THE BONE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORT: (B)(4) (2916714-2022-00103) AE-QAS-K521-56. (B)(4) (2916714-2022-00104 ) AE-QAS-K521-56.

  Patient problems: Failure of Implant

  MAUDE report 15605328 ↗