SIGMA 96-0017Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295232063), received between Nov 28, 2018 and Nov 28, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (3 reports).

7 other recalls cover devices cleared under the same FDA submission (K241000, K961685); they may or may not involve this specific model.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2018Material Discolored; Material Discolored

  IT WAS REPORTED THAT THERE IS STAINING/DISCOLORATION ON THE FEMORAL KNEE IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8110743 ↗
• MalfunctionNov 28, 2018Material Discolored; Material Discolored

  IT WAS REPORTED THAT THERE IS STAINING/DISCOLORATION ON THE FEMORAL KNEE IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8110731 ↗
• MalfunctionNov 28, 2018Material Discolored; Material Discolored

  IT WAS REPORTED THAT THERE IS STAINING/DISCOLORATION ON THE FEMORAL KNEE IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8110706 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K961685. One submission often covers many models, so check the product and lot details in each record.

• Z-0057-2007 · Sep 14, 2006 · Terminated
  Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
• Z-1315-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 97-0340.
• Z-1318-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361.
• Z-1316-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 97-0352.
• Z-1317-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353.
• Z-1319-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 10.0 Ref 97-0371.
• Z-1320-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 15.0 mm; Ref 97-0373.