APEX CR Knee KC-1135RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841690100959), received between Jun 29, 2018 and Apr 10, 2021 — classified as 4 injuries.

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

• InjuryApr 10, 2021Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6)2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2018. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, SURGEON REMOVED ORIGINAL TIBIAL INSERT, FEMORAL COMPONENT AND RETAINING BOLT AND REPLACED THEM WITH NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 11646654 ↗
• InjuryOct 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6)2020. THE ORIGINAL SURGERY DATE IS UNKNOWN. THE REASON FOR REVISION IS REPORTED SCAR TISSUE FROM PATIENT FALL. DURING THE REVISION THE ORIGINAL FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Fall; Scar Tissue

  MAUDE report 10673020 ↗
• InjuryJun 3, 2020Loosening of Implant Not Related to Bone-Ingrowth

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY IS DATE IS UNKNOWN. THE REASON FOR REVISION IS REPORTED FEMORAL LOOSENING. DURING THE REVISION THE ORIGINAL TIBIAL INSERT AND FEMUR WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10114820 ↗
• InjuryJun 29, 2018Loose or Intermittent Connection; Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2013. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED INSTABILITY/LOOSENING. DURING THE REVISION, THE ORIGINAL OMNI SIZE 3+ RIGHT CR FEMORAL COMPONENT, SIZE 3 X 10MM ULTRA INSERT, TIBIAL BASEPLATE RETAINING BOLT, SIZE 3 RIGHT TIBIAL BASEPLATE, AND 32X8MM PATELLA DOME WERE REMOVED AND REPLACED WITH SIZE 3+ RIGHT REVISION FEMUR, SIZE 3 MODULAR TIBIAL BASEPLATE, TIBIAL BASEPLATE RETAINING BOLT, REVISION TIBIA PEG, 15MMX125MMX2MM MODULAR OFFSET STEM, AND 11MMX100MMX4MM MODULAR OFFSET STEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7652770 ↗