NA 02.221.080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982275684), received between Nov 11, 2025 and Nov 11, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT 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. 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), 69-YEAR-OLD FEMALE. PATIENT EXPERIENCED OSTEOMYELITIS REQUIRING THE REMOVAL OF A LOOSE PLATE AND IRRIGATION AND DEBRIDEMENT. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2023. IMPLANT(S) INVOLVED: 02.221.080 (1). UNKNOWN CABLE (1), 3.5MM LOCKING SCREW (1).

  Patient problems: Unspecified Infection

  MAUDE report 23527749 ↗
• 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), 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), 58-YEAR-OLD FEMALE. PATIENT EXPERIENCED TROCHANTERIC BURSITIS REQUIRING PLATE TO BE REMOVED. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2023.

  Patient problems: Inflammation

  MAUDE report 23522901 ↗