PROFIX 71504325Recalls & reported problems
Smith & Nephew, Inc. · PROFIX 6.5 TIBIAL SCREW 25MM · Class 2
All models of PROFIX (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010219763), received between Aug 7, 2018 and Aug 9, 2018 — classified as 5 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Loose or Intermittent Connection4
- Insufficient Device Problem Information1
Patient problems
- Limited Mobility Of The Implanted Joint1
- Missing Value Reason1
- No Information1
- Pain1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RIGHT KNEE LOOSENING AND LEFT KNEE PAIN.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7770732 ↗InjuryAug 9, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RIGHT KNEE LOOSENING AND LEFT KNEE PAIN.
Patient problems: Limited Mobility Of The Implanted Joint
MAUDE report 7770550 ↗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 7769186 ↗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 7758096 ↗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: Missing Value Reason
MAUDE report 7758048 ↗
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page