NA 2598-07-390Recalls & reported problems
Depuy (Ireland) · TISSUE SPARING SOLUTIONS TISSUE SPARING FEM CORE CASE 1 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy surgical instrument tray holds the tissue-sparing femoral core instruments used in hip surgery. The 39 reports mostly describe the tray and its holders breaking down: trays peeling or cracking, brackets bending with plastic coverings chipping away, rivets falling out, and surfaces that can no longer be cleaned and sterilized properly. No deaths or injuries were reported, and in most cases the patient was unaffected. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295148333), received between Jul 9, 2018 and Apr 28, 2026 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (30 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/Delaminated30
- Break9
- Material Deformation7
- Material Integrity Problem4
- Contamination /Decontamination Problem3
- Crack3
- Appropriate Device Problem Term/Code Not Available1
- No Apparent Adverse Event1
Patient problems
- No Consequences Or Impact To Patient20
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION AND THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25014624 ↗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 24790212 ↗MalfunctionSep 15, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
IT WAS REPORTED THAT THE TISSUE SPARING FEMORAL CORE CASE 1 AND TISSUE SPARING FEMORAL CORE CASE 2 INSTRUMENT BRACKETS ARE BENT, AND THEIR PLASTIC COVERINGS ARE CHIPPING AWAY. THE MDR DEPARTMENT STATES THAT THESE PANS CAN NO LONGER BE CLEANED AND STERILIZED EFFECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051827 ↗MalfunctionSep 15, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
IT WAS REPORTED THAT THE TISSUE SPARING FEMORAL CORE CASE 1 AND TISSUE SPARING FEMORAL CORE CASE 2 INSTRUMENT BRACKETS ARE BENT, AND THEIR PLASTIC COVERINGS ARE CHIPPING AWAY. THE MDR DEPARTMENT STATES THAT THESE PANS CAN NO LONGER BE CLEANED AND STERILIZED EFFECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051806 ↗MalfunctionSep 15, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
IT WAS REPORTED THAT THE TISSUE SPARING FEMORAL CORE CASE 1 AND TISSUE SPARING FEMORAL CORE CASE 2 INSTRUMENT BRACKETS ARE BENT, AND THEIR PLASTIC COVERINGS ARE CHIPPING AWAY. THE MDR DEPARTMENT STATES THAT THESE PANS CAN NO LONGER BE CLEANED AND STERILIZED EFFECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051777 ↗MalfunctionSep 15, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
IT WAS REPORTED THAT THE TISSUE SPARING FEMORAL CORE CASE 1 AND TISSUE SPARING FEMORAL CORE CASE 2 INSTRUMENT BRACKETS ARE BENT, AND THEIR PLASTIC COVERINGS ARE CHIPPING AWAY. THE MDR DEPARTMENT STATES THAT THESE PANS CAN NO LONGER BE CLEANED AND STERILIZED EFFECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051774 ↗MalfunctionSep 15, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
IT WAS REPORTED THAT THE TISSUE SPARING FEMORAL CORE CASE 1 AND TISSUE SPARING FEMORAL CORE CASE 2 INSTRUMENT BRACKETS ARE BENT, AND THEIR PLASTIC COVERINGS ARE CHIPPING AWAY. THE MDR DEPARTMENT STATES THAT THESE PANS CAN NO LONGER BE CLEANED AND STERILIZED EFFECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051769 ↗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 19365173 ↗MalfunctionFeb 27, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE THREE TRAYS WITH PEELING PAINT WERE REJECTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18788341 ↗MalfunctionOct 19, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAY IS PEELING APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17966265 ↗MalfunctionJul 24, 2023Peeled/Delaminated; Peeled/Delaminated
DEVICE REPORT FROM DEPUY SYNTHES CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT SEVERAL CORE CASE 1 PANS ARE PEELING IN A NUMBER OF DIFFERENT AREAS. NO PATIENT CONSEQUENCE OR DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17383590 ↗MalfunctionJul 24, 2023Peeled/Delaminated; Peeled/Delaminated
DEVICE REPORT FROM DEPUY SYNTHES CANADA REPORTS AN EVENT AS FOLLOWS:IT WAS REPORTED THAT SEVERAL CORE CASE 1 PANS ARE PEELING IN A NUMBER OF DIFFERENT AREAS. NO PATIENT CONSEQUENCE OR DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17382802 ↗MalfunctionJul 24, 2023Peeled/Delaminated; Peeled/Delaminated
DEVICE REPORT FROM DEPUY SYNTHES CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT SEVERAL CORE CASE 1 PANS ARE PEELING IN A NUMBER OF DIFFERENT AREAS. NO PATIENT CONSEQUENCE OR DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17382287 ↗MalfunctionJul 24, 2023Peeled/Delaminated; Peeled/Delaminated
DEVICE REPORT FROM DEPUY SYNTHES CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT SEVERAL CORE CASE 1 PANS ARE PEELING IN A NUMBER OF DIFFERENT AREAS. NO PATIENT CONSEQUENCE OR DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17381944 ↗MalfunctionJul 24, 2023Peeled/Delaminated; Peeled/Delaminated
DEVICE REPORT FROM DEPUY SYNTHES CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT SEVERAL CORE CASE 1 PANS ARE PEELING IN A NUMBER OF DIFFERENT AREAS. NO PATIENT CONSEQUENCE OR DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17380775 ↗MalfunctionJul 24, 2023Peeled/Delaminated; Peeled/Delaminated
DEVICE REPORT FROM DEPUY SYNTHES CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT SEVERAL CORE CASE 1 PANS ARE PEELING IN A NUMBER OF DIFFERENT AREAS. NO PATIENT CONSEQUENCE OR DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17380421 ↗MalfunctionMay 18, 2023Peeled/Delaminated; Peeled/Delaminated
THE CORE CASE 1 PAN IS PEELING AND CANNOT BE USED ANYMORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16952877 ↗MalfunctionAug 10, 2021Break; Peeled/Delaminated; Break; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE MISSING PARTS (BROKE OFF). TRAYS ARE PEELING. LIDS ARE BROKEN AND THROWN OUT. COATING IS PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12302568 ↗MalfunctionAug 10, 2021Break; Peeled/Delaminated; Break; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE MISSING PARTS (BROKE OFF). TRAYS ARE PEELING. LIDS ARE BROKEN AND THROWN OUT. COATING IS PEELING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12302502 ↗MalfunctionApr 30, 2020Break; Material Deformation; Material Integrity Problem; Break; Material Deformation; Material Integrity Problem
ITEMS ARE WORN AND NEEDS TO BE REPLACED. NOTHING FELL INTO PATIENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. QUANTITIES IMPACTED AND NEEDING REPLACEMENT ARE BELOW (2 AND 4 EACH).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10016105 ↗MalfunctionApr 30, 2020Break; Crack; Material Integrity Problem; Break; Crack; Material Integrity Problem
ITEMS ARE WORN AND NEEDS TO BE REPLACED. NOTHING FELL INTO PATIENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. QUANTITIES IMPACTED AND NEEDING REPLACEMENT ARE BELOW (2 AND 4 EACH).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10016083 ↗MalfunctionApr 30, 2020Break; Material Integrity Problem; Break; Material Integrity Problem
ITEMS ARE WORN AND NEEDS TO BE REPLACED. NOTHING FELL INTO PATIENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. QUANTITIES IMPACTED AND NEEDING REPLACEMENT ARE BELOW (2 AND 4 EACH).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10016075 ↗MalfunctionApr 30, 2020Break; Material Deformation; Material Integrity Problem; Break; Material Deformation; Material Integrity Problem
ITEMS ARE WORN AND NEEDS TO BE REPLACED. NOTHING FELL INTO PATIENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. QUANTITIES IMPACTED AND NEEDING REPLACEMENT ARE BELOW (2 AND 4 EACH).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10015805 ↗MalfunctionMar 3, 2020Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE BRACKETS INSIDE THE TRAY WERE PEELING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9781762 ↗MalfunctionOct 22, 2019Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem
PANS ARE DELAMINATING AND CANNOT BE STERILIZED PROPERLY. NEED THE PAN, LID, AND INSERT ALL SENT FOR REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9219094 ↗
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- n.a. 39501XKKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
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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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