PROFIX 71501010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010218391), received between Aug 7, 2018 and Nov 30, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2023Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER RIGHT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN. FURTHERMORE, X-RAYS ON (B)(6) 2023 SHOWED LUCENCY UNDER THE TIBIAL COMPONENTS PARTICULARLY IN THE PRO METAPH TIB STEM 18MM, THIS FINDINGS WOULD SUGGEST LOOSENING OF THE PROTHESES. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY PERFORMED ON (B)(6) 2023, IN WHICH A LGN POR HA TIB BASE W/O HOLES SZ 7 RT,LGN CR HIGH FLEX XLPE SZ 7-8 9MM AND A PRO METAPH TIB STEM 18MM WERE EXCHANGED. PATIENT AS FAR AS ACKNOWLEDGED IS FIT AND HEALTHY.

  Patient problems: Arthralgia; Inadequate Osseointegration; Pain; Radiolucent Lines

  MAUDE report 18238266 ↗
• InjuryNov 30, 2023Fracture; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Fracture; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER LEFT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN. FURTHERMORE, X-RAYS ON (B)(6) 2023 SHOWED LUCENCY UNDER THE TIBIAL COMPONENT PARTICULARLY IN THE PRO METAPH TIB STEM 18MM, THIS FINDINGS WOULD SUGGEST LOOSENING OF THE PROTHESES. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY PERFORMED ON (B)(6) 2023, IN WHICH A LGN POR HA TIB BASE W/O HOLES SZ 7 LT, PRO METAPH TIB STEM 18MM AND A LGN CR HIGH FLEX XLPE SZ 7-8 9MM WERE EXCHANGED. PATIENT AS FAR AS ACKNOWLEDGED IS FIT AND HEALTHY.

  Patient problems: Arthralgia; Inadequate Osseointegration; Pain; Radiolucent Lines

  MAUDE report 18238074 ↗
• InjuryAug 28, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY FOR A PRODUCT REMOVAL WAS PERFORMED.

  Patient problems: Injury; No Code Available

  MAUDE report 7824702 ↗
• InjuryAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RIGHT KNEE LOOSENING AND LEFT KNEE PAIN.

  Patient problems: Pain

  MAUDE report 7767351 ↗
• InjuryAug 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RIGHT KNEE LOOSENING AND LEFT KNEE PAIN.

  Patient problems: Pain

  MAUDE report 7760144 ↗
• InjuryAug 7, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING KNEE.

  Patient problems: No Information

  MAUDE report 7757351 ↗