NA 02.221.122SRecalls & reported problems
Synthes GmbH · 3.5/4.5MM VA PPFX PROX FEMUR PLATE/10HOLES/RIGHT/STERILE · Class 2 · Implant
Data updated Oct 18, 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 10886982275905), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE 10 HOLE RIGHT VA PPFX STANDARD PLATE OPENED WITH SMALL RIGHT VA GT RING ATTACHMENT PLATE. AFTER REPEATED ATTEMPTS THE SCRUB NURSE SURGEON AND REGISTRAR COULD NOT CONNECT THE TWO. THIS WAS DONE ON THE TABLE NOT IN THE PATIENT. IT WAS LINED UP PERFECTLY AS FAR AS I COULD SEE BUT THE CONNECTING SCREW ON THE GT RING PLATE SEEMED TOO BIG FOR THE HOLE IN THE PPFX STANDARD PLATE NO MATTER HOW MUCH PERSEVERANCE OR ANTI CLOCKWISE TURNS TO TRY AND GET IT TO DROP INTO PLACE OR ALTERING THE ANGLE OF THE SCREWDRIVER/SCREW WORKED. AFTER THIS A SECOND PFPX PLATE 11 HOLE THIS TIME AND A SECOND GT RING PLATE LARGE RIGHT WERE OPENED TO TRY AND ELIMINATE ISSUES WITH EITHER THE HOLE OR THE CONNECTION SCREW. NO COMBINATION OF THESE IMPLANTS WERE ABLE TO BE PUT TOGETHER. A SECOND SCRUB NURSE CAME TO THE TABLE AND TRIED TO ASSEMBLE THE PRODUCTS FOR A FURTHER 30 MINUTES WHILE THE SURGEON CONTINUED WITH THE OPERATION. AFTER THE CASE WAS FINISHED, I ATTEMPTED TO ASSEMBLE THE PRODUCTS AND FAILED. THE SURGEON FINISHED THE OPERATION USING THE STANDARD PLATE ONLY BUT HAS SAID THE OPERATION AND OUTCOME COULD BE COMPROMISED DUE TO THE INABILITY TO ASSEMBLE THE PRODUCTS AND GAIN THE ADDITIONAL
Patient problems: Insufficient Information
MAUDE report 23280321 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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