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
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 ↗
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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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