NA 02.221.153SRecalls & reported problems
Synthes GmbH · 3.5MM VA PPFX DSTL FEMUR SPAN ATTCHMT PL/4H LNG/LEFT/STER · 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 10886982276629), received between Apr 21, 2025 and Apr 21, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SUBJECT (B)(6), CLINICAL ADVERSE EVENTS RECEIVED FOR EXCESSIVE BLEEDING, DEVICE AND PROCEDURE(RELATEDNESS), DEVICE RELATED: RELATED TO DEVICE, PROCEDURE RELATED: RELATED TO PROCEDURE, DATE OF EVENT: JANUARY 08, 2025, DATE OF IMPLANT: ON (B)(6) 2025, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: NO INFORMATION PROVIDED, TREATMENT/IMPACT: NO INFORMATION PROVIDED. DEPUY SYNTHES PRODUCT USED: CATALOG NUMBER: 02.221.153S, LOT NUMBER: NO INFORMATION PROVIDED, COMPONENT TYPE: PLATE, DESCRIPTION: DPS - VA LOCKING PPFX DISTAL FEMUR SPANNING ATTACHMENT PLATE 3.5.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21874664 ↗
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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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