ADVANCE® KIMP210LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684KIMP210L1), received between Nov 21, 2019 and Nov 22, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2022Insufficient Device Problem Information

  ALLEGEDLY, PT UNDERWENT PRIMARY L TKR ON (B)(6) 2004. REVISED ON (B)(6) 2021 DUE TO PAIN. 10MM INSERT REMOVED AND REPLACED WITH 17MM INSERT. (B)(4).

  Patient problems: Pain

  MAUDE report 15845683 ↗
• InjuryMar 23, 2022Naturally Worn; Naturally Worn

  ALLEGEDLY, THE FEMORAL COMPONENT BROKE AND CAUSED A LAMENESS IN THE PATIENT AND PAIN IN HIS KNEE. THE INSERT HAS RESULTING WEAR.

  Patient problems: Pain

  MAUDE report 13860699 ↗
• InjuryMar 3, 2021Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(4). SIDE: L. PRIMARY ASA: MILD DISEASE NOT INCAPACITATING. MHRA REFERENCE NO: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11404638 ↗
• InjuryOct 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR , ASEPTIC LOOSENING TIBIA , LYSIS FEMUR AND LYSIS TIBIA. REVISION NJR NUMBER: (B)(4). SIDE:L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Osteolysis

  MAUDE report 10659280 ↗
• InjuryNov 21, 2019Difficult to Insert; Difficult to Insert

  ALLEGEDLY, THE INSERT DID NOT ENTER THE TIBIAL TRAY, IT WAS CHECKED THAT EVERYTHING WAS FINE, BUT EVEN THOUGH MANEUVERS WERE MADE TO IMPACT IT, IT DID NOT ENTER AND GENERATED THE DETACHMENT OF THE TIBIAL TRAY, WHICH HAD ALREADY BEEN POSITIONED AND CEMENTED, IN THE END A HIGHER INSERT WAS USED, THE SURGERY TIME EXTENDED WAS GREATER THAN 30MIN.

  Patient problems: No Information

  MAUDE report 9356924 ↗