NA 02.221.086Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982275578), received between Sep 26, 2023 and Nov 11, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 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). ATTACHED 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 NUMBER (B)(4), 70-YEAR-OLD MALE. PATIENT EXPERIENCED OSTEOMYELITIS REQUIRING PLATE REMOVAL AND IRRIGATION AND DEBRIDEMENT. DATE OF ORIGINAL SURGERY WAS (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 23522599 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). IT WAS REPORTED CLINICAL ADVERSE EVENTS RECEIVED FOR SYMPTOMATIC HARDWARE. PATIENT WAS IMPLANTED WITH HARDWARE ON (B)(6) 2024. PATIENT WAS INDICATED FOR REMOVAL OF HARDWARE TO TREAT. SYMPTOMATIC HARDWARE CAUSING PAIN. DATE OF REVISION UNKNOWN. THIS REPORT IS FOR ONE 3.5/4.5MM VA PPFX PROX FEMUR HOOK PL/LARGE/5HOLES/RIGHT.

  Patient problems: Pain

  MAUDE report 20175985 ↗
• MalfunctionSep 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2023 DURING A SURGERY, THE SURGICAL TECH SAID THE PISTOL GRIP CABLE TENSIONER WAS VERY COMPLICATED. THE SURGEON USED IT SUCCESSFULLY, AND THE CABLES WERE SUCCESSFULLY PLACED. THERE WERE NO ALLEGATIONS AGAINST THE FUNCTIONING OF THE DEVICE. ADDITIONALLY THE SURGEON SAID A PROXIMAL FEMUR HOOK PLATE WAS TOO BULKY FOR THE PATIENT AND DECIDED TO USE A DIFFERENT OPTION. THERE WAS NO ISSUES WITH THE PLATE ITSELF, IT WAS JUST HOW IT FIT THE PATIENTS ANATOMY. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME: STABLE. CONCOMITANT DEVICE REPORTED: UNK - CABLE/WIRE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 3.5/4.5 VA PROX FEMUR HOOK PL/LRG/217/RT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818184 ↗