NA 2598-07-400Recalls & reported problems
Depuy (Ireland) · TISSUE SPARING SOLUTIONS TISSUE SPARING FEM CORE BASE 1 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295148340), received between Aug 23, 2019 and Apr 6, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated2
- Break1
- Crack1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Peeled/Delaminated
IT WAS REPORTED THAT DURING A HIP SURGERY, THE RIVETS FROM THE TISSUE SPARING FEM CORE DEVICES WERE FALLING OUT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24790214 ↗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 19365046 ↗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 8927514 ↗
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- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- Calibrate CLCCXSIMPAAlphatec Spine, Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501BECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501XKKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501A2Karl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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