ADVANCE® KIDH310RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684KIDH310R1), received between Aug 5, 2020 and Nov 17, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Unstable” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY OF HIS RIGHT KNEE. POLY INSERT WAS EXCHANGED FOR A THICKER SIZE. INFORMATION RECEIVED FROM WILL MALATESTA ON 11/03/2020: PRODUCT ID AND LOT INFORMATION. COMPONENTS NOT REVISED: ADVANCE® PRIMARY FEMORAL SIZE 3 RIGHT POROUS PRODUCT NUMBER: KFTCPC3R LOT BATCH: 1728111. ADVANCE STATURE® FEMUR SIZE 4 LEFT POR PRODUCT NUMBER: KFTCPN4L LOT BATCH: 1729076. ADVANCE® BIOFOAM® TIBIA BASE W/O SCREWHOLES SIZE 3 PRODUCT NUMBER: KTSLFM31 LOT BATCH: 1669461.

  Patient problems: No Information

  MAUDE report 10850632 ↗
• InjuryAug 5, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY AND PAIN OF HIS RIGHT KNEE. POSSIBLY HAS A RUPTURED PCL (POSTERIOR CRUCIATE LIGAMENT). COMPONENTS NOT REVISED: RIGHT FEMUR PRODUCT ID: KFTCPC3R LOT #: 1537324; 3+ BIOTIB BASE PRODUCT ID: KTSCFM31 LOT #: 1524649; 35MM PATELLA PRODUCT ID: KPON35MB LOT : 1549486.

  Patient problems: Pain

  MAUDE report 10371292 ↗