ADVANCE® KPONTP32Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M684KPONTP321), received between Apr 13, 2021 and Nov 14, 2024 — classified as 7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT HAVING PROBLEMS SINCE HAD THE RIGHT KNEE REPLACEMENT DONE.

  Patient problems: Insufficient Information

  MAUDE report 20682741 ↗
• InjuryMar 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT L TKR ON (B)(6) 2018. REVISED ON (B)(6) 2024 DUE TO INFECTION. ALL COMPONENTS REVISED WITH THE EVOLUTION REVISION SYSTEM. AUSTRALIA-C24-065.

  Patient problems: Unspecified Infection

  MAUDE report 18841832 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, REPORTER BECAME AWARE OF SOME NITRX COMPLAINTS FROM A SURGEON IN (B)(6) HOWEVER, NO INFORMATION ABOUT THE COMPLAINTS WERE GIVEN TO REPORTER. MICROPORT ORTHOPEDICS VP R&D PROD. DEVELOPMENT STATED THAT HE RECEIVED A PHONE CALL FROM (B)(4) (SALES REP) SAYING THAT A DOC IN (B)(6) HAD A FEW PATIENTS COME BACK IN WITH PAINFUL, SWOLLEN KNEES. HE CONTACTED THE REP TO SEE IF HE COULD GET MORE DETAILS. HE ASKED A SERIES OF QUESTIONS THAT HE DID NOT KNOW THE ANSWER. NO PART/LOT NUMBERS ARE GIVEN AND IT HAS NOT BEEN INDICATED HOW MANY EVENTS/PATIENTS HAVE OCCURRED REGARDING THESE ISSUES. ADDITIONAL INFORMATION RECEIVED ON 10/05/2022: A TOTAL OF 8 COMPLAINTS WERE RECEIVED WITH ALL RELEVANT INFORMATION INCLUDED IN EACH INCIDENT FORM. THE 7 REMAINING COMPLAINTS ARE CAPTURED UNDER DIFFERENT MICROPORT INCIDENT GROUP NUMBERS. ALLEGEDLY, RECURRING KNEE EFFUSION. NO INFECTION TO DATE. IT WAS CONFIRMED THAT EACH OF THESE PATIENTS WERE SEEN FOR FOLLOW-UP APPOINTMENTS TO ADDRESS INFLAMMATION IN THEIR KNEES. THE SURGEON CONFIRMED THAT NONE OF THE PATIENTS HAD INFECTIONS AND THAT THEIR KNEES HAD FLUID BUILDUP THAT WAS DRAINED. THE SURGEON HAS NOT BEEN ABLE TO DETERMINE IF THESE EVENTS WERE CAUSE

  Patient problems: Fluid Discharge; Inflammation; Pain

  MAUDE report 15712003 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, REPORTER BECAME AWARE OF SOME NITRX COMPLAINTS FROM A SURGEON IN (B)(6) HOWEVER, NO INFORMATION ABOUT THE COMPLAINTS WERE GIVEN TO REPORTER. MICROPORT ORTHOPEDICS VP R&D PROD. DEVELOPMENT STATED THAT HE RECEIVED A PHONE CALL FROM (B)(6)(SALES REP) SAYING THAT A DOC IN (B)(6) HAD A FEW PATIENTS COME BACK IN WITH PAINFUL, SWOLLEN KNEES. HE CONTACTED THE REP TO SEE IF HE COULD GET MORE DETAILS. HE ASKED A SERIES OF QUESTIONS THAT HE DID NOT KNOW THE ANSWER. NO PART/LOT NUMBERS ARE GIVEN AND IT HAS NOT BEEN INDICATED HOW MANY EVENTS/PATIENTS HAVE OCCURRED REGARDING THESE ISSUES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: A TOTAL OF 8 COMPLAINTS WERE RECEIVED WITH ALL RELEVANT INFORMATION INCLUDED IN EACH INCIDENT FORM. THE 7 REMAINING COMPLAINTS ARE CAPTURED UNDER DIFFERENT MICROPORT INCIDENT GROUP NUMBERS. ALLEGEDLY, RECURRING KNEE EFFUSION. NO INFECTION TO DATE. IT WAS CONFIRMED THAT EACH OF THESE PATIENTS WERE SEEN FOR FOLLOW-UP APPOINTMENTS TO ADDRESS INFLAMMATION IN THEIR KNEES. THE SURGEON CONFIRMED THAT NONE OF THE PATIENTS HAD INFECTIONS AND THAT THEIR KNEES HAD FLUID BUILDUP THAT WAS DRAINED. THE SURGEON HAS NOT BEEN ABLE TO DETERMINE IF THESE EVENTS WERE CAUSE

  Patient problems: Fluid Discharge; Inflammation; Pain

  MAUDE report 15668842 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, A PATIENT IMPLANTED WITH MPO COMPONENTS ON JUNE 21ST HAS EXPERIENCED A RASH ON HER SKIN. THE PATIENT HAS SALMONELLA AND SHE HAS HAD THREE SURGERIES AND CANNOT GET RID OF THE RASH. THEREFORE, THE SURGEON IS REQUESTING FOR THE METAL AND PLASTIC COMPOSITION OF THE COMPONENTS TO DETERMINE IF THE PATIENT IS EXPERIENCING AN ALLERGIC REACTION TO THE IMPLANT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13860978 ↗
• InjuryJun 15, 2021Use of Device Problem; Human-Device Interface Problem; Use of Device Problem; Human-Device Interface Problem

  ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2020. PATELLA REVISED ON (B)(6) 2021 DUE TO SURGICAL ERROR AS THE PATELLA CUT WAS AT ABOUT 30 DEGREES TO INTERCONDYLAR NOTCH. PATELLA REMOVED, RECUT & CEMENTED A NEW PATELLA. (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 11997133 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(6). SIDE: R. PRIMARY ASA: P1 - FIT AND HEALTHY. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11657422 ↗