P.F.C. SIGMA 96-0826Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295234104), received between Nov 30, 2017 and Dec 14, 2022 — classified as 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TOTAL KNEE EXPLANT WAS PERFORMED DUE TO KNEE JOINT INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2014, DOR: (B)(6) 2022, AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15983796 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TOTAL KNEE EXPLANT WAS PERFORMED DUE TO KNEE JOINT INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2014. DOR: (B)(6) 2022. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15983792 ↗
• InjuryMar 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTED LEFT KNEE. EXTRACTION OF COMPONENTS AND INSERTION OF ANTIBIOTIC SPACER WERE DONE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE AFFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 13925417 ↗
• 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 13593846 ↗
• 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 13593844 ↗
• 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 13593831 ↗
• 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 13593819 ↗
• 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 13593805 ↗
• 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 13592305 ↗
• 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 13592302 ↗
• 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 13592301 ↗
• 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 13592299 ↗
• 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 13592288 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO LOOSENING REPORTED. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12719448 ↗
• InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8146787 ↗
• InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8146715 ↗
• InjuryOct 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS FALL, PAIN AND LOOSENING OF THE FEMUR TO FEMORAL COMPONENT AND BOLT TO FEMORAL ADAPTOR AT THE BONE TO CEMENT AND CEMENT TO IMPLANT.

  Patient problems: Not Applicable; Pain

  MAUDE report 7940257 ↗
• InjuryAug 7, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS METALLOSIS AND LOOSENING OF THE STEM BOLT AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT POLY SWAP SINCE DOING THE REVISION. DOI: (B)(6) 2001; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Tissue Damage

  MAUDE report 7756905 ↗
• InjuryNov 30, 2017Malposition of Device; Malposition of Device

  PATIENT INITIATED COMPLAINT; MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED FOR TIBIAL MALPOSITIONING, POLY WEAR, METALLOSIS, AND FEMORAL LOOSENING AT AN UNKNOWN INTERFACE/CEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7071445 ↗