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K-15 PORK 74027438Recalls & reported problems

Smith & Nephew, Inc. · POROUS OVAL PATELLA SZ 38MM · Class 2 · Implant

All models of K-15 PORK (13)

Data updated Oct 18, 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 00885556769850), received between Apr 19, 2022 and Apr 19, 2022 — classified as 1 injury.

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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCE AN INFECTION AFTER 6 WEEKS. THE ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 TO EXPLANT THE FEMUR, TIBIA, INSERT AND PATELLAR COMPONENTS. PATIENT'S CURRENT STATUS OF HEALTH IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 14149139 ↗

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

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