SCP® Knee Kit 414.503Recalls & reported problems
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024205321), received between Apr 24, 2019 and Dec 29, 2020 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Migration1
Patient problems
- Calcium Deposits/Calcification1
- Not Applicable1
- Pain1
- Pulmonary Embolism1
- Swelling1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED THAT THE PATIENT DEVELOPED A PULMONARY EMBOLISM WITHIN ONE (1) FOLLOWING A RIGHT KNEE SUBCHONDROPLASTY PROCEDURE AND WAS TREATED ORALLY. THE PATIENT'S TREATMENT WAS REPORTED TO BE ONGOING.
Patient problems: Pulmonary Embolism
MAUDE report 11092433 ↗InjurySep 22, 2020Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain; Swelling
MAUDE report 10566444 ↗InjuryApr 25, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
CLINICAL SUBJECT (B)(6) EXPERIENCED DELAYED SCP HARDENING (B)(6) 2019.
Patient problems: Not Applicable
MAUDE report 8552238 ↗InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CALCIFICATION AND ACUTE PAIN AFTER SCP.
Patient problems: Calcium Deposits/Calcification
MAUDE report 8544650 ↗
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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