Knee Instruments 11.01033Recalls & reported problems
Medacta International SA · Sphere Insert Instrument Set I3R-T3/4 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030878619), received between Dec 20, 2017 and Dec 20, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2017Break; Break
DURING TIBIAL FINISHING PROCESS, POSITIONED THE TRIAL BASEPLATE ON THE RESECTED TIBIA AND PREPARED THE KEEL HOLE. AFTER THAT, THE SURGEON TRIED TO ENGAGE TRIAL INSERT FLEX S3R 10MM, BUT IT WAS NOT ABLE TO FIX. AFTER MANY ATTEMPTS, TRIAL INSERT WAS NOT COMPLETELY FIXED, BUT HE SELECTED THE SUITABLE TRIAL TIBIAL INSERT SIZE. AFTER THE REMOVAL OF TRIAL TIBIAL INSERT, HE FOUND THAT THE POSTERIOR SIDE OF TRIAL KEEL AND TRIAL TIBIAL BASEPLATE WERE CRACKED. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 5 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7134060 ↗
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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