SIGMA LCS 9505-02-018Recalls & reported problems
Depuy Orthopaedics, Inc. · SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE MBT PUNCH CEMENTED SZ 4-7 · Class 1
All models of SIGMA LCS (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295227380), received between Aug 24, 2017 and Jul 24, 2020 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (6 reports).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Jan 8, 2016Terminated
Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery.
Z-0787-2016 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Naturally Worn6
- Break4
- Entrapment of Device1
Patient problems
- No Consequences Or Impact To Patient8
- No Information2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2020Break; Entrapment of Device; Break; Entrapment of Device
THE INSTRUMENT´S BOTH "NOSES" OF THE LOCKING MECHANISM BROKE OFF. ONE METAL FRAGMENT WAS FOUND REMAINING IN PATIENT, THE WHEREABOUTS OF THE SECOND FRAGMENT IS UNKNOWN. PATIENT UNDERWENT PRIMARY KNEE-TEP LEFT SIDE ON (B)(6) 2020, IT IS UNKNOWN WHETHER BOTH FRAGMENTS BROKE OFF ON THIS DATE/DURING THIS SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10321179 ↗MalfunctionApr 1, 2019Break; Break
IT WAS REPORTED THAT THE METAL PIECE OF SZ 4-7 KEEL PUNCH BROKE OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8471047 ↗MalfunctionMar 27, 2018Naturally Worn; Naturally Worn
CUSTOMER COLLECTED DEFECTIVE INSTRUMENTS: THE INSTRUMENT´S LOCKING MECHANISM IS WORN. THE PUNCHES DON´T FIT PROPERLY ANY LONGER. NO SURGERY PROLONGATION REPORTED, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED, NO PART REMAINING IN PATIENT BODY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7372928 ↗MalfunctionMar 27, 2018Naturally Worn; Naturally Worn
CUSTOMER COLLECTED DEFECTIVE INSTRUMENTS: THE INSTRUMENT´S LOCKING MECHANISM IS WORN. THE PUNCHES DON´T FIT PROPERLY ANY LONGER. NO SURGERY PROLONGATION REPORTED, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED, NO PART REMAINING IN PATIENT BODY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7372914 ↗MalfunctionMar 27, 2018Naturally Worn; Naturally Worn
CUSTOMER COLLECTED DEFECTIVE INSTRUMENTS: THE INSTRUMENT´S LOCKING MECHANISM IS WORN. THE PUNCHES DON´T FIT PROPERLY ANY LONGER. NO SURGERY PROLONGATION REPORTED, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED, NO PART REMAINING IN PATIENT BODY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7372896 ↗MalfunctionMar 27, 2018Naturally Worn; Naturally Worn
CUSTOMER COLLECTED DEFECTIVE INSTRUMENTS: THE INSTRUMENT´S LOCKING MECHANISM IS WORN. THE PUNCHES DON´T FIT PROPERLY ANY LONGER. NO SURGERY PROLONGATION REPORTED, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED, NO PART REMAINING IN PATIENT BODY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7372769 ↗MalfunctionMar 27, 2018Naturally Worn; Naturally Worn
CUSTOMER COLLECTED DEFECTIVE INSTRUMENTS: THE INSTRUMENT´S LOCKING MECHANISM IS WORN. THE PUNCHES DON´T FIT PROPERLY ANY LONGER. NO SURGERY PROLONGATION REPORTED, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED, NO PART REMAINING IN PATIENT BODY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7372742 ↗MalfunctionMar 27, 2018Naturally Worn; Naturally Worn
CUSTOMER COLLECTED DEFECTIVE INSTRUMENTS: THE INSTRUMENT´S LOCKING MECHANISM IS WORN. THE PUNCHES DON´T FIT PROPERLY ANY LONGER. NO SURGERY PROLONGATION REPORTED, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED, NO PART REMAINING IN PATIENT BODY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7372739 ↗MalfunctionOct 25, 2017Break; Break
ONE "NOSE" OF THE LOCKING MECHANISM BROKE OFF.
Patient problems: No Information
MAUDE report 6975843 ↗MalfunctionAug 24, 2017Break; Break
ONE "NOSE" OF THE LOCKING MECHANISM BROKE OFF.
Patient problems: No Information
MAUDE report 6819362 ↗
Other PUNCH, SURGICAL devices
- SIGMA LCS HIGH PERFORMANCE 9505-02-012Depuy Orthopaedics, Inc. · PUNCH, SURGICAL85 reports
- DJO SURGICAL 801-05-040Encore Medical, L.P. · PUNCH, SURGICAL1 recall7 reports
- SIGMA LCS 9505-02-017Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall1 report
- SIGMA LCS 9505-02-016Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-021Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-020Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA HIGH PERFORMANCE 9505-02-047Depuy (Ireland) · PUNCH, SURGICAL33 reports
- SIGMA LCS HIGH PERFORMANCE 9505-02-011Depuy Orthopaedics, Inc. · PUNCH, SURGICAL30 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 · each recall links to the FDA recall notice
- 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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