SIGMA LCS 9505-02-806Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT TIBIA PREP CASE · Class 1
All models of SIGMA LCS (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295229346), received between Jan 10, 2019 and Dec 19, 2019 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (10 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.
Most reported problems
Device problems
- Peeled/Delaminated10
- Material Twisted/Bent6
- Break4
- Naturally Worn4
- Adverse Event Without Identified Device or Use Problem2
- Crack2
Patient problems
- No Consequences Or Impact To Patient10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2019Crack; Peeled/Delaminated; Material Twisted/Bent; Crack; Peeled/Delaminated; Material Twisted/Bent
IT WAS REPORTED THAT THE TRAYS ARE WORN AND OLD. NEED TO BE REPLACED. PLASTIC INSTRUMENT HOLDERS IN TRAYS ARE CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9493392 ↗MalfunctionDec 19, 2019Crack; Peeled/Delaminated; Material Twisted/Bent; Crack; Peeled/Delaminated; Material Twisted/Bent
IT WAS REPORTED THAT THE TRAYS ARE WORN AND OLD. NEED TO BE REPLACED. PLASTIC INSTRUMENT HOLDERS IN TRAYS ARE CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9493385 ↗MalfunctionDec 6, 2019Peeled/Delaminated; Peeled/Delaminated
THE VARNISHING OF TRAY IS EXFOLIATING. SEEN IN CSSD. NO PATIENT INVOLVEMENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9432399 ↗MalfunctionDec 6, 2019Peeled/Delaminated; Peeled/Delaminated
THE VARNISHING OF TRAY IS EXFOLIATING. SEEN IN CSSD. NO PATIENT INVOLVEMENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9432327 ↗MalfunctionOct 30, 2019Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn; Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9257639 ↗MalfunctionOct 30, 2019Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn; Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9257636 ↗MalfunctionOct 30, 2019Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn; Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9257632 ↗MalfunctionOct 30, 2019Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn; Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9257631 ↗MalfunctionJan 10, 2019Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem
THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8235757 ↗MalfunctionJan 10, 2019Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem
THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8235722 ↗
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
- 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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