Evolution ETPKN6SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M684ETPKN6SL1), received between Jun 24, 2021 and Oct 21, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

• InjuryOct 21, 2024Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  ALLEGEDLY, PATIENT IS SCHEDULE FOR REVISION DUE TO LEFT KNEE FEMORAL AND TIBIAL LOOSENING, PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 20501297 ↗
• InjuryJun 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: L. GENDER: M.

  Patient problems: Unspecified Infection

  MAUDE report 19619959 ↗
• InjuryMay 16, 2023Packaging Problem; Noise, Audible; Packaging Problem; 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: Insufficient Information; Pain

  MAUDE report 16939638 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 6. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. PRODUCTS NO REVISED: PRODUCT ID: EFSRN6PL, LOT: 1671546, QTY: 1. PRODUCT ID: EIS6S10L, LOT: 1663651, QTY: 1.

  Patient problems: Unspecified Infection

  MAUDE report 15744898 ↗
• InjuryNov 7, 2022Unexpected Therapeutic Results

  ALLEGEDLY, REPORTER BECAME AWARE OF SOME NITRX COMPLAINTS FROM A SURGEON IN IDAHO 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 MIKE SHATZER(SALES REP) SAYING THAT A DOC IN IDAHO 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 AND (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 THE

  Patient problems: Fluid Discharge; Inflammation; Pain

  MAUDE report 15743615 ↗
• InjuryAug 3, 2022Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, COMPLETE FEMORAL AND TIBIAL BIPOLAR LOOSENING, MAJOR OSTEOLYSIS OF THE FEMORAL EPIPHYSIS AND METAPHYSIS PRESERVING THE CORTICALS, ABUNDANT FIBRINOUS TISSUE, DIFFUSE DEPOSITS OF INTRA-OSSEOUS AND INTRA-ARTICULAR FIBRIN. LESS OSTEOLYSIS AT THE TIBIAL LEVEL. NO ISSUE WITH THE PATELLA.

  Patient problems: Osteolysis

  MAUDE report 15158857 ↗
• InjuryJun 24, 2021Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO LAXATION AND INSTABILITY. (B)(6) (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12060741 ↗