SCP® Knee Kit 414.502Recalls & reported problems
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024205314), received between May 10, 2019 and Oct 21, 2025 — classified as 12 injuries.
The most frequently reported specific device problem is “Fracture” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Appropriate Device Problem Term/Code Not Available3
- Fracture3
Patient problems
- Extravasation4
- Foreign Body In Patient3
- Pain2
- Loss of Range of Motion1
- Necrosis1
- No Code Available1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 23348079 ↗InjuryAug 30, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE CANNULA BROKE OFF IN THE FEMUR AND WAS RETAINED BY THE PATIENT. NO OTHER PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 15319754 ↗InjuryDec 17, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 13025062 ↗InjuryOct 29, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
(B)(6) HAD EXTRUSION OF ACCUFILL INTO THE KNEE JOINT DURING SURGERY.
Patient problems: Extravasation
MAUDE report 10754948 ↗InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT 06-010 EXPERIENCING LEFT KNEE PAIN AFTER SCP SURGERY.
Patient problems: Pain
MAUDE report 9886139 ↗InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 10, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
13-006 HAD EXTRUSION OF ACCUFILL INTO THE KNEE JOINT DURING SURGERY.
Patient problems: Extravasation
MAUDE report 9174429 ↗InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EXTRAVASATION OF ACCUFILL WAS NOTED DURING THE INDEX PROCEDURE OF CLINICAL STUDY SUBJECT (B)(6).
Patient problems: Extravasation
MAUDE report 8995519 ↗InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLINICAL STUDY SUBJECT (B)(6) EXPERIENCED DECREASED RANGE OF MOTION AFTER SCP.
Patient problems: Loss of Range of Motion
MAUDE report 8995462 ↗InjuryJul 23, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
NOTIFICATION DATE: 22 JAN 2019. PATIENT'S STATS BEGAN TO DROP UPON INJECTION.
Patient problems: No Code Available
MAUDE report 8817626 ↗InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLINICAL STUDY SUBJECT (B)(6) EXPERIENCED INTRA-ARTICULAR LEAKAGE OF ACCUFILL IN THE MEDIAL TIBIAL PLATEAU.
Patient problems: Extravasation
MAUDE report 8599351 ↗InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLINICAL SUBJECT (B)(6) EXPERIENCED INCREASED PAIN AFTER SCP SURGERY.
Patient problems: Pain
MAUDE report 8599334 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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