NA 02.120.606Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982040183), received between Sep 6, 2024 and Nov 17, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 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 SAINT VINCENT HOSPITAL AND HEALTH CARE CENTER, AS PART OF AN ON-GOING DATA USE AGREEMENT. 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)(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. IMPLANT(S) INVOLVED: 02.221.120 (1). 02.221.150 (1). 02.120.606

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Unspecified Infection

  MAUDE report 23567767 ↗
• 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). THE PRELIMINARY DATA REPORT WAS FROM THE (B)(6), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6) HOSPITAL AND (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 NUMBER (B)(4), 45-YEAR-OLD FEMALE. PATIENT EXPERIENCED OSTEOMYELITIS REMOVAL OF IMPLANTS AND CONVERSION TO THA.

  Patient problems: Unspecified Infection

  MAUDE report 23525709 ↗
• 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). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6) HOSPITAL AND HEALTH CARE CENTER, 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 NUMBER (B)(6), 45-YEAR-OLD FEMALE. PATIENT EXPERIENCED OSTEOMYELITIS REQUIRING IRRIGATION AND DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 23524037 ↗
• 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). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6) HEALTH CARE CENTER, 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 NUMBER (B)(6), 45-YEAR-OLD FEMALE. PATIENT EXPERIENCED PAIN REQUIRING REVISION. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 23523352 ↗
• 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)(6), 70-YEAR-OLD MALE. PATIENT EXPERIENCED OSTEOMYELITIS REQUIRING PLATE REMOVAL AND IRRIGATION AND DEBRIDEMENT. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 23522715 ↗
• 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 (B)(6) 2024 AT (B)(6) HEALTH SYSTEMS. PATIENT NUMBER 14 (75-YEAR-OLD FEMALE) -HISTORY OF BIPOLAR DISORDER, HYPOTHYROIDISM, GERD, ANXIETY, DEPRESSION. IMPLANTS WERE PLACED DUE TO PROXIMAL FEMUR PERIPROSTHETIC FRACTURE. POST-OP COMPLICATION FOR PLATE FAILURE AT 27 WEEKS POST-OP. RELATED TO BOTH DEVICE AND PROCEDURE. SURGEON INDICATED OSTEOPOROSIS WAS CONFIRMED TO BE THE MAIN CAUSE OF THE REOPERATION. TREATMENT INCLUDED ALL PPFX HARDWARE REMOVAL AND CONVERSION TO PROXIMAL FEMUR REPLACEMENT.

  Patient problems: Bone Fracture(s); Osteopenia/ Osteoporosis

  MAUDE report 20159167 ↗
• InjurySep 6, 2024Off-Label Use; Off-Label Use

  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 (B)(6) 2021 TO (B)(6) 2024 AT WAKE FOREST UNIVERSITY HEALTH SYSTEMS. PATIENT NUMBER 10 (56-YEAR-OLD FEMALE) - HISTORY OF DDD, ANKLE ARTHRITIS, LUMBAR RADICULOPATHY & SPONDYLOSIS. IMPLANTS WERE PLACED DUE TO PROXIMAL FEMUR PERIPROSTHETIC FRACTURE. POST-OP COMPLICATION FOR POST-OP WOUND INFECTION AND DEHISCENCE. THIS IS RELATED TO THE PROCEDURE. TREATMENT INCLUDED SURGICAL INTERVENTION AND ANTIBIOTICS. THE PATIENT REPORTED USING THE DISTAL SPANNING ATTACHING PLATE (DSAP) WITH THE DEPUY CURVE CONDYLAR PERIARTICULAR PLATE FOR A PROXIMAL FEMUR PERIPROSTHETIC FRACTURE. THE DSAP WAS NOT DESIGNED FOR USAGE WITH THIS PARTICULAR PLATE; THUS, THIS CASE WAS CONSIDERED OFF-LABEL.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 20158146 ↗