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NA 02.221.124Recalls & reported problems

Synthes GmbH · 3.5/4.5MM VA PPFX PROX FEMUR PLATE/11HOLES/RIGHT · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982275547), received between Apr 3, 2023 and Sep 18, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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: 2 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem3
  • Break1
  • Device-Device Incompatibility1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Nonunion/Delayed-union Bone Fracture2
  • Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING SURGERY FOR BILATERAL PERIPROSTHETIC FRACTURES, USERS ENDED UP USING FOUR DIFFERENT HOOK PLATES. TWO WERE NOT BILLED TO THE PATIENT DUE TO THE THREADED PORTION NOT CONNECTING WITH THE HANDLE. TWO HANDLES SEEMED TO BE CROSS THREADED. THE 11H R VASTUS RIDGE PLATE DID NOT HAVE SCREWS THAT LOCKED IN. THERE WERE NO PATIENT CONSEQUENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23082487 ↗
  • InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CLINICAL ADVERSE EVENT RECEIVED FOR NONUNION: DEVICE RELATED: NO. PROCEDURE RELATED: YES. DATE OF EVENT: 2024-12-05. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: NO INFORMATION PROVIDED. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 04.233.220S. LOT NUMBER: NO INFORMATION PROVIDED. COMPONENT TYPE: RETROGRADE FEMORAL NAIL ADVANCED; 12MM; 200MM; 5° BEND - STERILE) RADE FEMORAL NAIL ADVANCED; 12MM; 200MM; 5° BEND - STERILE). DESCRIPTION: DPS - RETROGRADE FEMORAL NAIL ADVANCED. CATALOG NUMBER: 02.221.124. LOT NUMBER: NO INFORMATION PROVIDED. COMPONENT TYPE: VA-LCP PPFX PROXIMAL FEMUR PLATE 3.5/4.5/5.0; 11 HOLES; MM; STAINLESS STEEL. DESCRIPTION: DPS - VA-LCP PPFX PROXIMAL FEMUR PLATE 3.5/4.5/5.0.

    Patient problems: Nonunion/Delayed-union Bone Fracture

    MAUDE report 21586291 ↗
  • InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    SUBJECT (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR FIXATION FAILURE, DISPLACEMENT OF SCREWS DEVICE AND PROCEDURE (RELATEDNESS): YES DATE OF EVENT: 2025-02-13 DATE OF IMPLANT: (B)(6) 2023 . TREATMENT/IMPACT:

    Patient problems: Nonunion/Delayed-union Bone Fracture

    MAUDE report 21562834 ↗
  • 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 DECEMBER 2021 TO APRIL 2024. PATIENT NUMBER (B)(6): IMPLANTS WERE PLACED DUE TO PROXIMAL FEMUR PERIPROSTHETIC FRACTURE. INTRA-OPERATIVE COMPLICATION FOR HEAVY BLOOD LOSS AND DECREASE IN HEMOGLOBIN. PATIENT WAS GIVEN 1UNIT OF PACKED RED BLOOD CELLS AND 3LS OF CRYSTALLOIDS. THIS IS RELATED TO THE PROCEDURE.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 20158025 ↗
  • MalfunctionApr 3, 2023Break; Break

    IT WAS REPORTED THAT ON MARCH 15, 2023, UPON INSPECTION OF THE PLATE, IT WAS DISCOVERED THAT ONE OF THE TANGS OF THE LOCKING SCREW HOLES IN THE PLATE HAD BROKEN OFF. THE PLATE WAS NOT USED DURING THE CASE, THE CST NOTICED BEFORE THE CASE. IT WILL NEED TO BE REPLACED IN THE SET. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM/4.5MM VA PROX FEMUR PL 357MM/RIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16663280 ↗

Other Plate, fixation, bone devices

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Sources and updates

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