P.F.C. SIGMA 96-0849Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295234227), received between Nov 29, 2021 and Feb 25, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (2 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

Recent adverse event reports

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

• MalfunctionFeb 25, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH OPERATOR WAS PERFORMING THE WI-0897 ¿REPACKAGING / RESTERILIZATION OF STERILE PRODUCT IN RAYNHAM¿ FOR A PFC SIGMA AUGMENT REPACKAGING ORDER. DURING THIS PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. THE OPERATOR NOTIFIED THE FINISH LEAD, WHO CONTACTED PROCESS AND QUALITY ENGINEERING FOR FURTHER EVALUATION. THE IMAGE ATTACHED SHOWS A AUGMENT RETURNED FROM EXPIRY WITH FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13598510 ↗
• MalfunctionFeb 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ON (B)(6) 2022, A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH OPERATOR WAS PERFORMING THE WI-0897 ¿REPACKAGING / RESTERILIZATION OF STERILE PRODUCT IN RAYNHAM¿ FOR A PFC SIGMA AUGMENT REPACKAGING ORDER. DURING THIS PROCESS, THE OPERATOR IDENTIFIED MULTIPLE PARTS DISPLAYED A VISUAL COSMETIC DEFECT ON THE TOP SURFACE. THE OPERATOR NOTIFIED THE FINISH LEAD, WHO CONTACTED PROCESS AND QUALITY ENGINEERING FOR FURTHER EVALUATION. THE IMAGE ATTACHED SHOWS A AUGMENT RETURNED FROM EXPIRY WITH FOAM PARTICLES TRANSFERRED FROM THE PACKAGING COMPONENTS. ON (B)(6) 2021 12 PARTS WERE DISCOVERED WITH DEFECTS (CAPTURED ON (B)(4) ON (B)(6) 2022, AN ADDITIONAL 12 PARTS WERE DISCOVERED WITH DEFECTS (CAPTURED ON (B)(4)). LATER ON (B)(6) 2022, AN ADDITIONAL 29 PARTS WERE DISCOVERED WITH DEFECTS (CAPTURED ON (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13593746 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE PRIMARY SURGERY. THIS PC REPORTS ABOUT THE REMOVAL SURGERY DUE TO INFECTION. AFTER THE REVISION TKA SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL SURGERY ON NOVEMBER 9, 2021 BECAUSE INFECTION OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12882768 ↗