ACTIS 2010-04-500Recalls & reported problems
Depuy (Ireland) · ACTIS CORE CASE BASE · Class 1
All models of ACTIS (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy Actis core case base, the plastic tray that holds hip replacement instruments during surgery. The 28 reports mostly describe the black coating peeling or flaking off the tray, along with cracking, chipping, and staining of the rubber, often after repeated washing and sterilizing. No deaths and no injuries are reported, and no recalls name 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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295393917), received between Apr 27, 2023 and Feb 2, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (24 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated24
- Crack4
- Contamination /Decontamination Problem3
- Break2
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2026Peeled/Delaminated
IT WAS CONFIRMED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT THA FOR OA WITH THE PRODUCTS IN QUESTION. BEFORE THE SURGERY, THE HOSPITAL FOUND A LOT OF BLACK FRAGMENTS IN CASE. THE BLACK PLASTIC PART IN CASE WAS PEELED OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PRODUCT IN QUESTION IS A CONSIGNED ITEM, SO IT APPEARS TO HAVE BEEN REPEATEDLY WASHED AND STERILIZED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24241116 ↗MalfunctionNov 18, 2025Crack; Contamination /Decontamination Problem; Crack; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE PANS ARE OLD. PLASTIC IN PANS ARE STARTING TO CRACK AND ALL RUBBER WAS STAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23587329 ↗MalfunctionAug 18, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT, AND THE PRODUCT WAS CHIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22829987 ↗MalfunctionJul 2, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PINNACLE UTILITY CASE AND ACTIS CORE CASE BASE ARE PEELING, ACTIS FLX REAMER CASE BASE REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384216 ↗MalfunctionMay 12, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT WHILE SETTING UP THIS ACTIS CORE TRAY IT WAS DISCOVERED THAT A SECTION OF THE BLACK COVERING OF THE INTERNAL FRAME THAT HOLDS THE INSTRUMENTS WAS PEELING AWAY. THIS TRAY WAS REMOVED FROM USE IMMEDIATELY. THERE WAS NO IMPACT TO ANY PATIENT BECAUSE THIS WAS FOUND BEFORE IT WAS USED FOR A CASE. THIS DER IS NOT ASSOCIATED WITH A SURGICAL CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22003626 ↗MalfunctionFeb 4, 2025Crack; Peeled/Delaminated; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE HOSPITAL IS COMPLAINING ABOUT TRAYS DUE TO CHIPPING, PEELING, CRACKING AND OUTER RUBBER PEELING OFF. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21305866 ↗MalfunctionFeb 4, 2025Crack; Peeled/Delaminated; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE HOSPITAL IS COMPLAINING ABOUT TRAYS DUE TO CHIPPING, PEELING, CRACKING AND OUTER RUBBER PEELING OFF. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21305738 ↗MalfunctionFeb 4, 2025Crack; Peeled/Delaminated; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE HOSPITAL IS COMPLAINING ABOUT TRAYS DUE TO CHIPPING, PEELING, CRACKING AND OUTER RUBBER PEELING OFF. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21305669 ↗MalfunctionDec 3, 2024Break; Peeled/Delaminated; Break; Peeled/Delaminated
IT WAS REPORTED THAT THERE WAS A CHIPPED TRAY AND WAS DENIED BY SPD. THERE WERE NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20833302 ↗MalfunctionOct 24, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE TRAYS HAS DAMAGED.
Patient problems: Insufficient Information
MAUDE report 20522438 ↗MalfunctionAug 21, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE INNER BLACK LINING IS PEELING OFF. HOSPITAL WILL NOT STERILIZE TRAY DUE TO THIS REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20015684 ↗MalfunctionAug 20, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE INNER BLACK LINING IS PEELING OFF. HOSPITAL WILL NOT STERILIZE TRAY DUE TO THIS REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20007125 ↗MalfunctionJul 23, 2024Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED STATES THAT DURING THE VISUAL EXAMINATION ON (02/11/2025), IT WAS OBSERVED THAT THE DEVICES (201004600/PV0158603; 201004600/PV0204733; 201004600/PV0195574) HAD PEELING COATINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806910 ↗MalfunctionJul 23, 2024Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED STATES THAT DURING THE VISUAL EXAMINATION ON (02/11/2025), IT WAS OBSERVED THAT THE DEVICES (201004600/PV0158603; 201004600/PV0204733; 201004600/PV0195574) HAD PEELING COATINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806665 ↗MalfunctionJul 23, 2024Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED STATES THAT DURING THE VISUAL EXAMINATION ON (B)(6) 2025), IT WAS OBSERVED THAT THE DEVICES (201004600/PV0158603; 201004600/PV0204733; 201004600/PV0195574) HAD PEELING COATINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806648 ↗MalfunctionJul 23, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE FLAKING DEBRIS. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806643 ↗MalfunctionJun 17, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAY IS PEELING. SPD WILL NOT PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19555045 ↗MalfunctionApr 4, 2024Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT ON (B)(6) 2024 THE DAMAGED TRAYS WERE FLAKING. THE HOSPITAL IS DEEMED THEM CONTAMINATED FOR PROCEDURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19039873 ↗MalfunctionApr 4, 2024Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem
IT WAS REPORTED THAT ON (B)(6) 2024 THE DAMAGED TRAYS WERE FLAKING. THE HOSPITAL IS DEEMED THEM CONTAMINATED FOR PROCEDURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19039868 ↗MalfunctionMar 26, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT TRAYS WERE PEELING. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18984314 ↗MalfunctionMar 26, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT TRAYS WERE PEELING. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18984308 ↗MalfunctionMar 15, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE GRAPHIC INSTRUMENT CASES WERE FLAKING AND THE HOSPITAL DEEMED THE SETS CONTAMINATED FOR PROCEDURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913970 ↗MalfunctionMar 15, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE GRAPHIC INSTRUMENT CASES WERE FLAKING AND THE HOSPITAL DEEMED THE SETS CONTAMINATED FOR PROCEDURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913967 ↗MalfunctionMar 15, 2024Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION WAS RECEIVED: WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? - YES. PROCEDURES HAD TO BE RESCHEDULED. WAS THERE ANY PATIENT CONSEQUENCE RELATED TO THE EVENT? -NO, OTHER THAN HAVING TO RESCHEDULE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913902 ↗MalfunctionMar 15, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE GRAPHIC INSTRUMENT CASES WERE FLAKING AND THE HOSPITAL DEEMED THE SETS CONTAMINATED FOR PROCEDURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913891 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
- PINNACLE 2220-00-100Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT74 reports
- ACTIS 2010-04-200Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT66 reports
- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- n.a. 39501XKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6810Medical Action Industries 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
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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