ADVANCE® KPONTP35Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI M684KPONTP351), received between Aug 6, 2019 and May 16, 2023 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2023Noise, Audible; Noise, Audible

  ALLEGEDLY, PATIENT GOT A KNEE REPLACEMENT ON (B)(6) 2019, AND HAS BEEN EXPERIENCING PAIN ON IT EVER SINCE. PATIENT IS STATING HE NEEDS A REPLACEMENT BUT DOES NOT HAVE A DATE. THE KNEE IS POPPING AND CLICKING AND HAS BEEN SINCE THE INITIAL SURGERY.

  Patient problems: Pain

  MAUDE report 16939719 ↗
• InjuryJun 20, 2022Output Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ALLEGEDLY, 7 MONTHS POST OP HAD INCREASED WEIGHT BEARING PAIN. 44 MONTHS POST OP- NO COMPLAINT JUST VISIT TO DOCTOR BUT CAN SEE SOME LOOSENING. ON (B)(6) 2022 PATIENT WAS IN PAIN, HYPERFLEX OCCURRED IN SHOW DUE TO OTHER ISSUES COMPONENTS HAVE NOT BEEN REVISED. THIS WAS A PROPHECY CASE (B)(4).

  Patient problems: Pain

  MAUDE report 14750092 ↗
• InjuryJun 24, 2021Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO LAXATION AND INSTABILITY. (B)(6) C1128.

  Patient problems: Joint Laxity

  MAUDE report 12060711 ↗
• InjuryMay 13, 2021Fracture

  ALLEGEDLY, PATIENT FRACTURED HER PATELLA, ON REPAIRING THE BONE AN INFECTION WAS CAUSED. (B)(6) C1096 ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR ON 04/27/2021: ALLEGEDLY, THE PATELLA WAS NOT REVISED, PROXIMAL EDGE OF PATELLA FRACTURED FROM A TRAUMA PROSPECTIVE, ABOVE THE IMPLANTED POLY RESURFACED PATELLA.

  Patient problems: Bone Fracture(s)

  MAUDE report 11820449 ↗
• InjuryOct 28, 2020Noise, Audible; Noise, Audible

  ALLEGEDLY, PATIENT IS EXPERIENCING CLICKING AND PAIN WHEN SHE LAYS ON HER SIDE. NO FOLLOW UP WITH HER DOCTOR YET. ADDITIONAL INFORMATION RECEIVED ON 04/22/2020 FROM RELIABILITY ENGINEERING: PRODUCT ID AND LOT INFORMATION. ADDITIONAL INFORMATION RECEIVED ON 10/26/2020 FROM RELIABILITY ENGINEERING: UPDATED PRODUCT ID AND LOT INFORMATION.

  Patient problems: Pain

  MAUDE report 10748619 ↗
• InjuryJun 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 4478100. SIDE: L. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.

  Patient problems: Unspecified Infection

  MAUDE report 10206044 ↗
• InjuryJun 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 4356191. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Unspecified Infection

  MAUDE report 10200004 ↗
• InjuryJan 10, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2018, REVISED ON (B)(6) 2019 DUE TO INSTABILITY, 10MM TIBIAL INSERT INCREASED TO 17MM. WHILE REVISING THE SURGEON DECIDED TO REDUCE THE PATELLA FROM 35MM TO 32MM. (B)(6).

  Patient problems: No Information

  MAUDE report 9578230 ↗
• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, THE PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT ON (B)(6) 2014 AT (B)(6). ON (B)(6) 2014, THE PATIENTS C-REACTIVE PROTEIN (CPR) LEVEL WAS RECORDED AS HIGH AS 234MG/L. ON (B)(6) 2018, THE PATIENTS CPR LEVEL WAS RECORDED AS 284MG/L. SURGEON ADVISED THAT THE PATIENT WOULD REQUIRE 2 SURGERIES, OR LIFE-LONG ANTIBIOTICS IN ORDER TO TREAT THE CONDITION. (B)(6).

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 9410244 ↗
• InjuryOct 4, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION INSERT CHANGE LEFT TKR-POLY EXCHANGE. PATIENT LOOSE IN EXTENSION-LATERAL COMPARTMENT PATELLA LIFT OFF-PATELLA IMPLANT REMOVED-FRACTURE OBSERVED POST REMOVAL. 12MM LEFT CS INSERT REMOVED, 35MM PATELLA REMOVED. 14MM LEFT CS IMPLANTED. NO PATELLA REPLACED AND NO FIXATION OF PATELLA KNEE STABLE IN FLEXION AND EXTENSION.

  Patient problems: No Information

  MAUDE report 9157426 ↗
• InjuryAug 22, 2019Loose or Intermittent Connection; Failure to Osseointegrate; Loss of Osseointegration; Loose or Intermittent Connection; Failure to Osseointegrate; Loss of Osseointegration

  ALLEGEDLY THE LEFT KNEE ALWAYS HAD PAIN, FAILURE TO INTEGRATE ASEPTIC LOOSENING. DR. (B)(6) REMOVED THE FEMUR, TIBIA, POLY AND KEEL AND PATELLA WAS KEPT.

  Patient problems: Pain

  MAUDE report 8922874 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO STIFFNESS. REVISION NJR NUMBER: (B)(4). SIDE: L. PRIMARY ASA: P2-MILD DISEASE NOT INCAPACITATING. THE FOLLOWING COMPONENTS HAVE NO DEFICIENCY AND WERE NOT REVISED DURING THIS SURGERY: ADVANCE PRIMARY FEMORAL SIZE 4 LEFT NONPOROUS, KFTCNP4L, LOT # 1497882 QTY. 1; ADVANCE II COCR TIBIA BASE NONPOROUS SZ 4 STANDARD, KTCCNP40, LOT # NI QTY. 1.

  Patient problems: Loss of Range of Motion

  MAUDE report 8865598 ↗