NA 02.221.155SRecalls & reported problems
Synthes GmbH · 3.5MM VA PPFX DSTL FEMUR SPAN ATTCHMT PL/6H/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 10886982276636), received between Sep 6, 2024 and Sep 6, 2024 — 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
- Bone Fracture(s)1
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 14 PATIENTS THAT WERE IMPLANTED WITH 3.5/4.5 MM VA-LCP PERIPROSTHETIC PROXIMAL FEMUR PLATING SYSTEM. IMPLANTATION WAS BETWEEN (B)(6) 2024 AT (B)(6) HEALTH SYSTEMS. PATIENT NUMBER 14 (75-YEAR-OLD FEMALE) -HISTORY OF BIPOLAR DISORDER, HYPOTHYROIDISM, GERD, ANXIETY, DEPRESSION. IMPLANTS WERE PLACED DUE TO PROXIMAL FEMUR PERIPROSTHETIC FRACTURE. POST-OP COMPLICATION FOR PLATE FAILURE AT 27 WEEKS POST-OP. RELATED TO BOTH DEVICE AND PROCEDURE. SURGEON INDICATED OSTEOPOROSIS WAS CONFIRMED TO BE THE MAIN CAUSE OF THE REOPERATION. TREATMENT INCLUDED ALL PPFX HARDWARE REMOVAL AND CONVERSION TO PROXIMAL FEMUR REPLACEMENT.
Patient problems: Bone Fracture(s); Osteopenia/ Osteoporosis
MAUDE report 20159081 ↗
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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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