P.F.C. SIGMA 96-0842Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295234180), received between Feb 12, 2020 and Nov 11, 2024 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS INSTABILITY. INTRAOPERATIVELY, IT WAS IDENTIFIED THAT THE TIBIAL BASE PLATE WAS LOOSE (INTERFACE NOT PROVIDED) AND HAD SUBSIDED. IT WAS ALSO NOTED THAT THE WELL-FIXED FEMUR WAS MALPOSITIONED/INTERNALLY ROTATED AND WAS EXPLANTED ALONG WITH THE TIBIAL TRAY AND INSERT. THE PATELLA COMPONENT WAS WELL-FIXED AND WAS RETAINED. REVISION TIBIAL TRAY AND REVISION FEMUR, WITH SLEEVE AND STEM FOR BOTH SIDE CONSTRUCTS WERE IMPLANTED, THERE WERE NO COMPLICATIONS REPORTED. NO PRODUCT INFORMATION WAS PROVIDED IN THE RECORDS FOR REVISED PRIMARY IMPLANTS OR RETAINED PATELLA. THE RECORDS DID PROVIDE A PARTIAL RECORD OF THE REVISION IMPLANTS PLACED DURING ON (B)(6) 2018, REVISION--THESE APPEAR TO BE ONLY FOR THE FEMUR SIDE OF THE KNEE (DEPUY FEMUR, AUGMENTS, SLEEVE, AND STEM, AS WELL AS DEPUY CEMENT). ON (B)(6) 2022, PATIENT'S LEFT KNEE WAS REVISED AGAIN TO ADDRESS SEVERE PAIN AND GROSS INSTABILITY. INTRAOPERATIVELY, THE WELL-FIXED FEMUR COMPONENTS WERE EXPLANTED FROM THE FEMORAL SLEEVE AND STEM, WHICH WERE WELL-FIXED AND RETAINED. AN S-ROM NOILES HINGED FEMUR WITH 2 FEMORAL AUGMENTS WAS IMPLANTED ALONG WITH 12MM THICK HIN

  Patient problems: Joint Laxity; Pain

  MAUDE report 20658004 ↗
• MalfunctionFeb 24, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ON 31-JAN-2022, A CAST PRODUCT CLEANROOM (CPCR) 2ND SHIFT FINISH OPERATOR WAS PERFORMING THE WI-0897 ¿REPACKAGING / RESTERILIZATION OF STERILE PRODUCT IN (B)(4)¿ 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 15-DEC-2021 12 PARTS WERE DISCOVERED WITH DEFECTS (CAPTURED ON (B)(4)). ON 10-JAN-2022, AN ADDITIONAL 12 PARTS WERE DISCOVERED WITH DEFECTS (CAPTURED ON (B)(4)). LATER ON 31-JAN-2022, AN ADDITIONAL 29 PARTS WERE DISCOVERED WITH DEFECTS (CAPTURED ON (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13593842 ↗
• 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 13593742 ↗
• MalfunctionFeb 24, 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. THIS PC WAS CREATED TO CAPTURE THE PRODUCTS THAT ARE ALSO INVOLVE IN THE COMPLAINT REPORTED IN MAIN PC - (B)(4) AND (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592311 ↗
• MalfunctionFeb 24, 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. THIS PC WAS CREATED TO CAPTURE THE PRODUCTS THAT ARE ALSO INVOLVE IN THE COMPLAINT REPORTED IN MAIN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592303 ↗
• 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 (B)(6) 2021 BECAUSE INFECTION OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12882760 ↗
• InjuryJul 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO TREAT PAIN AND INFECTION. PATIENT RECEIVED A TWO-STAGE REVISION. DOI: (B)(6) 2021. DOR: (B)(6) 2021; UNK KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12225881 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INFECTION WAS CONFIRMED. AS THIS WAS A REVISION PROCEDURE, THERE WAS NO SURGICAL DELAY. THE PRODUCT SPECIALIST THINKS IT WAS A COMPETITORS CEMENT THAT WAS USED. ALL KNEE COMPONENTS WERE REMOVED, AND A TEMPORARY CEMENT SPACER WAS INSERTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12089644 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BROKE HER DISTAL FEMUR DUE TO FALL. A DISTAL FEMUR WITH SLEEVE AND STEM WAS USED TO GAIN STABILITY. ORIGINAL IMPLANT DATE WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9701637 ↗