NA 02.221.120Recalls & reported problems
Synthes GmbH · 3.5/4.5MM VA PPFX PROX FEMUR PLATE/9HOLES/RIGHT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982275523), received between Sep 4, 2024 and May 12, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).
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 Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
- Malunion of Bone1
- No Clinical Signs, Symptoms or Conditions1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026Device-Device Incompatibility
IT WAS REPORTED ON (B)(6) 2026, DURING THE SURGERY, ON THE SCRUB TABLE, THE SURGICAL TECHNICIAN WAS AFFIXING A GREATER TROCHANTER RING ATTACHMENT PLATE TO A PERIPROSTHETIC PROXIMAL FEMUR PLATE WHEN THE ATTACHMENT BOLT BECAME LODGED IN THE RECEIVING THREADS. THE BOLT WAS UNABLE TO ACHIEVE PROPER TORQUE AS IT FELL SHORT OF DEPTH, THEN REQUIRED PLIERS TO GET THE TWO PIECES APART. THERE WAS NO KNOWLEDGE OR EVIDENCE THAT EITHER IMPLANT HAD BEEN CONNECTED BEFORE THIS INSTANCE. NO SURGERY DELAYED DUE TO THE REPORTED EVENT. A DIFFERENT PLATE WAS USED. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS GENERATED. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148644 ↗InjuryNov 12, 2025Adverse 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 PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6), AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. A TOTAL OF 13 COMPLICATIONS HAVE BEEN REPORTED ACROSS 10 PATIENTS. SEVEN OF THESE LED TO REVISION OR REOPERATION SURGERIES, WITH TWO CASES CONSIDERED DEVICE RELATED¿SPECIFICALLY DUE TO ADVERSE TISSUE REACTION AND TROCHANTERIC BURSITIS. THE REMAINING REVISIONS WERE ASSOCIATED WITH PAIN, INFECTION, NONUNION, SEPSIS, AND HARDWARE PROMINENCE. OTHER REPORTED COMPLICATIONS INCLUDE POST-OPERATIVE AND INTRA-OPERATIVE FRACTURES, SUPERFICIAL INFECTION, AND ONE DEATH DUE TO NATURAL CAUSES. SUBJECT (B)(6), 60-YEAR-OLD FEMALE. PATIENT EXPERIENCED SEPTIC NONUNION. IRRIGATION AND DEBRIDEMENT WAS PERFORMED. THE PATIENT WAS ALSO IMPLANTED WITH A LOCKING PLATE AND AN ANTIBIOTIC NAIL. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2022.
Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture; Pain; Unspecified Infection
MAUDE report 23534208 ↗MalfunctionSep 4, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS FAILED TO CONNECT DURING SURGERY, FORCING SURGEONS TO USE DIFFERENT PLATE. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE 3.5MM/4.5MM VA PROX FEMUR PL 287MM/RIGHT THIS IS REPORT 4 OF 4 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 20137934 ↗
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- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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