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NA 2598-07-421Recalls & reported problems

Depuy (Ireland) · TISSUE SPARING SOLUTIONS TISSUE SPARING FEM CORE BASE 2 · Class 1

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295148388), received between Apr 17, 2019 and May 21, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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. How this data works · Data updated Oct 13, 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: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 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 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break3
  • Peeled/Delaminated2
  • Crack1

Patient problems

  • No Consequences Or Impact To Patient3
  • Insufficient Information1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 21, 2024Crack; Peeled/Delaminated; Crack; Peeled/Delaminated

    IT WAS REPORTED THAT ALL TRAYS WERE PEELING AND OR CRACKED.

    Patient problems: Insufficient Information

    MAUDE report 19365051 ↗
  • MalfunctionAug 23, 2019Break; Break

    IT WAS REPORTED THAT THE TRILOCK TOTAL HIP INSTRUMENT TRAYS WERE BEGINNING TO SHOW WEAR AND BREAK DOWN ON THE RUBBERIZED INSIDE PIECES. HOSPITAL REQUESTED THAT THE TRAYS BE REPLACED WITH NEW ONES. THIS DOES NOT INCLUDE ANY INSTRUMENTATION, JUST THE STERILIZATION TRAYS. NO REPORT OF HARM OR DELAY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8927518 ↗
  • MalfunctionAug 23, 2019Break; Break

    IT WAS REPORTED THAT THE TRILOCK TOTAL HIP INSTRUMENT TRAYS WERE BEGINNING TO SHOW WEAR AND BREAK DOWN ON THE RUBBERIZED INSIDE PIECES. HOSPITAL REQUESTED THAT THE TRAYS BE REPLACED WITH NEW ONES. THIS DOES NOT INCLUDE ANY INSTRUMENTATION, JUST THE STERILIZATION TRAYS. NO REPORT OF HARM OR DELAY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8927515 ↗
  • MalfunctionApr 17, 2019Break; Peeled/Delaminated; Break; Peeled/Delaminated

    PRODUCT CODE - 259807420 ¿ TISSUE SPARING FEM CORE CASE 2 - LOT D43CR4 - FAILURE DELAMINATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8522934 ↗

Other TRAY, SURGICAL, INSTRUMENT devices

All TRAY, SURGICAL, INSTRUMENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.