SPECIALIST 97-6750Recalls & reported problems
Depuy Orthopaedics, Inc. · SPECIALIST 2 RESURFACING PATELLAR REAMER BODY MEDIUM · Class 1
All models of SPECIALIST (12)
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 10603295251484), received between Aug 28, 2018 and May 30, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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
- Device-Device Incompatibility2
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BLADE GOT STUCK ON THE MEDIUM PATELLA REAMER AND DID NOT COME OFF. THE RED KNOB ON THE SIDE OF THE ATTUNE FEMORAL INTRODUCER FELL OFF WHEN IMPACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22114526 ↗MalfunctionOct 19, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DISPOSABLE CUTTING DEVICE WON¿T FIT ANYMORE INTO THIS BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12658530 ↗MalfunctionAug 28, 2018Mechanical Jam; Mechanical Jam
SIGMA PATELLA PLANING INSTRUMENT JAMMED AND REQUIRES REPLACEMENT. CSSS DE LAVAL, (B)(4). PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7822872 ↗
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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