NA 9505-01-035Recalls & reported problems
Depuy International Ltd · SP2 MI DISTAL FEMORAL CUTTING BLOCK · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295224372), received between Jun 30, 2020 and Aug 6, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device 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 18, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility1
- Material Twisted/Bent1
- Mechanical Jam1
- Naturally Worn1
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact To Patient3
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2020Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE TEETH ARE WORN AND BLOCK DOESN'T STAY IN THE JIG WELL. SEND REPLACEMENT SOS TO WNC OFFICE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10374736 ↗MalfunctionJul 29, 2020Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE BALANCER CALIBRATION DIALED ARE LOCKED [IE. WILL NOT SPIN]. THE DOCTOR WANTS THEM AT MILLIMETERS AND THEY ARE STUCK ON LCS NUMBERS. PLEASE SEND REPLACEMENT SOS TO (B)(4) OFFICE. THE CUTTING BLOCK DRILL HOLE BOUND UP AND THE PIN IS COLD WELDED IN PLACE. PLEASE SEND THE REPLACEMENT SOS TO (B)(4) OFFICE. NO ADDITIONAL INFORMATION ON EITHER. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10339515 ↗MalfunctionJun 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE DRILL PIN IN DISTAL BLOCK GOT STUCK AND COULD NOT BE REMOVED. NO ADDITIONAL INFORMATION AVAILABLE. PLEASE SEND REPLACEMENT TO 8 HOSPITAL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10213415 ↗
Other INSTRUMENT, CUTTING, ORTHOPEDIC devices
- SIGMA LCS 9505-01-230Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC95 reports
- ATTUNE 2544-00-522Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC58 reports
- SIGMA LCS 9505-01-229Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC56 reports
- SIGMA 2024-40-100Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC43 reports
- ATTUNE 2545-00-158Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- ATTUNE 2545-00-156Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- SIGMA 2024-40-200Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC40 reports
- ATTUNE 2545-00-155Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC39 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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