Knee Instruments 11.01035Recalls & reported problems
Medacta International SA · Sphere Insert Instrument Set I5R-T5 · Class 1
All models of Knee Instruments (33)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030878633), received between Jul 3, 2020 and Jul 3, 2020 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2020Adverse Event Without Identified Device or Use Problem
WHEN THE SURGEON TRIED TO IMPACT THE TRIAL KEEL WITH THE METAL HUMMER, THE TIBIA FRACTURED VERTICAL. THE POSSIBLE ROOT CAUSE OF THE FRACTURE WAS THE STRONG IMPACTION FORCE. SINCE THE FRACTURED BONE REPOSITIONED AFTER THE IMPLANTATION OF TIBIAL IMPLANTS, THE SURGERY FINISHED WITHOUT ANY ADDITIONAL TREATMENT. THE SURGEON EXPRESSED AN OPINION THAT HE DID NOT FEEL ANY RESISTANCE FORCE WHILE IMPACTING. THE METAL HAMMER WAS NOT MEDACTA'S DEVICE.
Patient problems: Bone Fracture(s)
MAUDE report 10228954 ↗
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- 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
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- 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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