PROFIX 71508121Recalls & reported problems
Smith & Nephew, Inc. · PROFIX CONFORMING PLUS TIBIAL INSERT RIGHT SIZE 2 10 · Class 2 · Implant
All models of PROFIX (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010220653), received between Jun 30, 2018 and Jun 30, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Component or Accessory Incompatibility” (1 report).
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
- Component or Accessory Incompatibility1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2018Component or Accessory Incompatibility; Component or Accessory Incompatibility
I WAS INFORMED BY DR (B)(6) TO PROVIDE IMPLANTS FOR THE ABOVE CASE. REQUESTED PROFIX INSERTS. INTRA-OPERATIVELY WE REALIZED THAT THE IMPLANTS INSITU WAS NOT A PROFIX KNEE AND WAS AN ADVANTUM KNEE INSTEAD DUE TO THE PROFIX INSERT NOT FITTING PROPERLY. I ADVISED THE SURGEON THAT THIS WAS THE CASE BUT DUE TO SURGERY IN PROGRESS, HE DECIDED TO STILL USE THE PROFIX INSERT AS THE ADVANTUM ONE WASN'T AVAILABLE. I ADVISED THE SURGEON THAT THE ARTICULATION WILL BE AFFECTED AND THIS WAS ACKNOWLEDGED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7653906 ↗
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- Taperloc Complete Micro Primary Femoral 51-106180Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER7 reports
- Taperloc Complete Micro Primary Femoral 51-108070Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER6 reports
- Taperloc Complete Micro Primary Femoral 51-106120Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER4 reports
- RTS M40 SE020In2Bones USA, LLC · Prosthesis, Toe, Constrained, Polymer3 reports
- SWANSON G4260102Wright Medical Technology, Inc. · PROSTHESIS, TOE, CONSTRAINED, POLYMER2 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.
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