P.F.C. SIGMA 96-0841Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295234173), received between Nov 9, 2017 and Feb 24, 2022 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 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 (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 13593841 ↗
• 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 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 13593839 ↗
• 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 13593828 ↗
• 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 13593816 ↗
• 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). .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592313 ↗
• 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 13592309 ↗
• 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 13592306 ↗
• 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592292 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE DOCTOR DECIDE TO REMOVE ALL COMPONENTS DO TO THIS INFECTION. IT WAS ALSO REPORTED THAT A FEMORAL IMPACTOR TIP BROKE OFF DURING THIS SURGERY. A COMPETITOR CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 11754177 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT KNEE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2014; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11517159 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, SYNOVITIS, TIBIAL INSERT WEAR, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN MANUFACTURER PRODUCTS WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED DURING THE REVISION. IT IS NOTED, AT THE END OF THE PROCEDURE, THE SURGEON REPORTED AN INTRAOPERATIVE DISTAL FEMORAL FRACTURE EXTENDING ABOUT 10 CM PROXIMALLY. THE FRACTURE WAS TREATED WITH 4 CERCLAGE WIRES AND NOTED TO BE STABLE. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, SWELLING, AND INFECTION. THE TIBIAL INSERT WAS EXCHANGED AND THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2020, 5-WEEK POST-OPERATIVE VISIT INDICATED SIGNIFICANT EFFUSION OF THE LEFT KNEE WITH MILD ERYTHEMA BUT NO OVERALL WARMTH. AFTER REVISION, THE PATIENT RECEIVED IV ANTIBIOTICS VIA A PICC LINE. THE PATIENT'S CRP WERE STILL ELEVATED COMPARED TO NORMAL, BUT WERE CONTINUING TO TREND DOWN. THIS PC CAPTURES THE EFFUSION AND IV ANTIBIOTICS ON (B)(6) 2020.

  Patient problems: Edema; Erythema; No Code Available

  MAUDE report 9748854 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, SYNOVITIS, TIBIAL INSERT WEAR, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN MANUFACTURER PRODUCTS WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED DURING THE REVISION. IT IS NOTED, AT THE END OF THE PROCEDURE, THE SURGEON REPORTED AN INTRAOPERATIVE DISTAL FEMORAL FRACTURE EXTENDING ABOUT 10 CM PROXIMALLY. THE FRACTURE WAS TREATED WITH 4 CERCLAGE WIRES AND NOTED TO BE STABLE. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, SWELLING, AND INFECTION. THE TIBIAL INSERT WAS EXCHANGED AND THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2020, 5-WEEK POST-OPERATIVE VISIT INDICATED SIGNIFICANT EFFUSION OF THE LEFT KNEE WITH MILD ERYTHEMA BUT NO OVERALL WARMTH. AFTER REVISION, THE PATIENT RECEIVED IV ANTIBIOTICS VIA A PICC LINE. THE PATIENT'S CRP WERE STILL ELEVATED COMPARED TO NORMAL, BUT WERE CONTINUING TO TREND DOWN. THIS PC CAPTURES THE EFFUSION AND IV ANTIBIOTICS ON (B)(6) 2020.

  Patient problems: Edema; Erythema; No Code Available

  MAUDE report 9748852 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, SYNOVITIS, TIBIAL INSERT WEAR, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN MANUFACTURER PRODUCTS WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED DURING THE REVISION. IT IS NOTED, AT THE END OF THE PROCEDURE, THE SURGEON REPORTED AN INTRAOPERATIVE DISTAL FEMORAL FRACTURE EXTENDING ABOUT 10 CM PROXIMALLY. THE FRACTURE WAS TREATED WITH 4 CERCLAGE WIRES AND NOTED TO BE STABLE. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, SWELLING, AND INFECTION. THE TIBIAL INSERT WAS EXCHANGED AND THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2020, 5-WEEK POST-OPERATIVE VISIT INDICATED SIGNIFICANT EFFUSION OF THE LEFT KNEE WITH MILD ERYTHEMA BUT NO OVERALL WARMTH. AFTER REVISION, THE PATIENT RECEIVED IV ANTIBIOTICS VIA A PICC LINE. THE PATIENT'S CRP WERE STILL ELEVATED COMPARED TO NORMAL, BUT WERE CONTINUING TO TREND DOWN. THIS PC CAPTURES THE INTRAOPERATIVE FEMUR FRACTURE ON (B)(6) 2014.

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

  MAUDE report 9748781 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, SYNOVITIS, TIBIAL INSERT WEAR, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN MANUFACTURER PRODUCTS WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED DURING THE REVISION. IT IS NOTED, AT THE END OF THE PROCEDURE, THE SURGEON REPORTED AN INTRAOPERATIVE DISTAL FEMORAL FRACTURE EXTENDING ABOUT 10 CM PROXIMALLY. THE FRACTURE WAS TREATED WITH 4 CERCLAGE WIRES AND NOTED TO BE STABLE. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, SWELLING, AND INFECTION. THE TIBIAL INSERT WAS EXCHANGED AND THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2020, 5-WEEK POST-OPERATIVE VISIT INDICATED SIGNIFICANT EFFUSION OF THE LEFT KNEE WITH MILD ERYTHEMA BUT NO OVERALL WARMTH. AFTER REVISION, THE PATIENT RECEIVED IV ANTIBIOTICS VIA A PICC LINE. THE PATIENT'S CRP WERE STILL ELEVATED COMPARED TO NORMAL, BUT WERE CONTINUING TO TREND DOWN. THIS PC CAPTURES THE INTRAOPERATIVE FEMUR FRACTURE ON (B)(6) 2014.

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

  MAUDE report 9748779 ↗
• InjuryNov 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS NICKEL ALLERGY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7016680 ↗
• InjuryNov 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS NICKEL ALLERGY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7016652 ↗