VEGA System® PS NX152Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963811020), received between Mar 25, 2021 and Mar 25, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA KNEE COMPONENTS. AS A RESULT OF HAVING AN AESCULAP PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN AND LOOSENING OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015, WHICH INCLUDED NON-AESCULAP IMPLANTS. A REVISION TO REPLACE NON-AESCULAP PRODUCTS WITH AESCULAP IMPLANTS OCCURRED ON (B)(6) 2017, AND THERE WAS NO REPORTED SECOND REVISION SURGERY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: (B)(4) (PS FEMUR CEMENTED F5N LT), (B)(4)(PS TIBIA CEMENTED T5), (B)(4) (PS PE INSERT T5, 14MM), (B)(4) (TIBIAL OBTURATOR D14MM, L7MM). ASSOCIATED MEDWATCHES: 2916714-2020-00396, 2916714-2020-00397, 2916714-2020-00399.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 11568811 ↗