NA 282.238Recalls & reported problems
Synthes GmbH · HELIX BLADE 95MM · Class 2 · Implant
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 10886982178244), received between May 8, 2020 and May 8, 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
- No Code Available1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO NON-UNION AND REVISION TO TOTAL HIP REPLACEMENT. THE ORIGINAL DATE OF IMPLANT WAS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED 135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 2 HOLES (PART NUMBER 282.61, LOT NUMBER H757389, QUANTITIES 1), SCREWS: CANNULATED (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITIES 1). THIS COMPLAINT IS FOR ONE (1) HELIX BLADE 95MM. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture
MAUDE report 10038829 ↗
Other DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT devices
- 13 X 90mm LAG FASTENER 324-13090Osteocentric Technologies, Inc. · Device, Fixation, Proximal Femoral, Implant1 report
- DHS 281.031Synthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- DHS 281.520SSynthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- DHS 280.285SSynthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- DHS 281.504Synthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- CONQUEST FN 71179203Smith & Nephew, Inc. · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) 1Orthofix Srl · Device, Fixation, Proximal Femoral, Implant1 report
- DHS 280.305Synthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
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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