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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

Other Plate, fixation, bone devices

All Plate, fixation, bone devices →

Sources and updates

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