Knee Instruments 11.01025Recalls & reported problems
Medacta International SA · Sphere Insert Instrument Set I5L-T5 · Class 1
All models of Knee Instruments (33)
Data updated Oct 16, 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 07630030878572), received between Apr 12, 2018 and May 9, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break3
Patient problems
- No Information2
- No Known Impact Or Consequence 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 9, 2018Break; Break
DURING SURGERY THE KEEL WING AND THE CONNECTION OF THE HANDLE WHERE HOLDS THE KEEL BROKE (THE TWO YELLOW TABS). THE SURGEON USED A SECONDARY SET OF INSTRUMENTS TO COMPLETE THE SURGERY.
Patient problems: No Information
MAUDE report 7498735 ↗MalfunctionMay 2, 2018Break; Break
DURING A GMK-EFFICIENCY BILATERAL CASE, THE KEELS FOR BOTH THE KNEES BROKE (THE MEDIAL SIDE OF ONE KEEL AND THE LATERAL FIN OF THE OTHER ONE). CONVENTIONAL INSTRUMENTS USED TO COMPLETE THE SURGERY SUCCESSFULLY. 10MIN DELAY. NO FRAGMENTS FELL INTO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7479656 ↗MalfunctionApr 12, 2018Break; Break
DURING SURGERY WHEN THE SURGEON WAS IMPACTING THE KEEL, THE WING OF THE INSTRUMENT BROKE. THE SURGEON USED A SECONDARY INSTRUMENT TO COMPLETE THE SURGERY.
Patient problems: No Information
MAUDE report 7425027 ↗
Other Orthopedic Manual Surgical Instrument devices
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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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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