SIGMA LCSRecalls & reported problems across all models

We found 5 models of SIGMA LCS by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Aug 24, 2017 and Jul 24, 2020 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (6 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SIGMA LCS recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 8, 2016Class IITerminated

   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 · names 5 of these models · Recall details · FDA record ↗

Most reported SIGMA LCS problems

SIGMA LCS models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SIGMA LCS 9505-02-018

  PUNCH, SURGICAL
  1 recall10 reports
• SIGMA LCS 9505-02-017

  PUNCH, SURGICAL
  1 recall1 report
• SIGMA LCS 9505-02-016

  PUNCH, SURGICAL
  1 recall0 reports
• SIGMA LCS 9505-02-020

  PUNCH, SURGICAL
  1 recall0 reports
• SIGMA LCS 9505-02-021

  PUNCH, SURGICAL
  1 recall0 reports

Recent SIGMA LCS adverse event reports

The 11 most recent reports across all models, 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 8, 2019Break; Break

  CSSD DEPARTMENT NOTICED THE KEEL PUNCH WAS BROKEN FOLLOWING THE CASE, AN X-RAY WAS DONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8490953 ↗
• 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 Depuy Orthopaedics, Inc. products

• PINNACLE ALTRX98 models · 5,631 reports
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• SUMMIT POROCOAT20 models · 1,646 reports
• PINNACLE GRIPTION57 models · 1,608 reports
• DURALOC93 models · 1,262 reports