APEX CR Knee KC-1145LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841690100966), received between Aug 27, 2018 and Nov 27, 2025 — classified as 4 injuries, 1 malfunction.

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

• InjuryNov 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  UNBEARABLE PAIN 18 DAYS POST SURGERY FOLLOWING AN APEX TOTAL KNEE REPLACEMENT.

  Patient problems: Implant Pain

  MAUDE report 23665998 ↗
• InjuryJul 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2025. THE ORIGINAL SURGERY DATE (B)(6) 2025. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION THE TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 22564113 ↗
• InjuryJul 6, 2022Unstable

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY IS DATED (B)(6) 2019. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE FEMUR, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Failure of Implant

  MAUDE report 14934274 ↗
• MalfunctionOct 30, 2020Patient-Device Incompatibility

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE SURGERY ON (B)(6) 2020. DURING THE SURGERY THE PATIENT WAS IMPLANTED WITH LEFT COMPONENTS INTO A RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10760254 ↗
• InjuryAug 27, 2018Loose or Intermittent Connection

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED LOOSENESS. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4+ LEFT CR FEMORAL COMPONENT, SIZE 4 X 10MM ULTRA INSERT, AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 4 LEFT PS FEMORAL COMPONENT, SIZE 4 X 14MM PS-C INSERT, AND A 14MM PS-C TIBIAL BASEPLATE RETAINING BOLT.

  Patient problems: No Code Available

  MAUDE report 7817843 ↗