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
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
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- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- INSTRUMENT 6541-9-109Howmedica Osteonics Corp. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6805Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501CECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 11580AKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.