P.F.C. SIGMA 86-6022Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295216773), received between Sep 29, 2017 and Mar 2, 2026 — classified as 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 reports).

16 other recalls cover devices cleared under the same FDA submission (K241000, K882234, K884796); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED REVISION SURGERY OCCURRED DUE TO PFC INFECTION WITH SIGNS OF UNSEALING. PROCEDURE COMPLETED WITH NO SURGICAL DELAY. PRIMARY TKA : (B)(6) 2006 (PROF. FRITSCHY). REVISION : (B)(6) 2026 (DR (B)(6)). SIDE: LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 24483036 ↗
• MalfunctionDec 13, 2022Difficult to Insert; Difficult to Insert

  ONE OF OUR CUSTOMERS, WHO USED SIGMA TIBIAL TRAY IN COCR VERSION SO FAR, FOR ECONOMIC REASONS HAD TO SWITCH TO A CHEAPER SOLUTION AND THAT IS FB MODULAR TITANIUM TRAY. AFTER THIS CHANGE HE CLAIMS THAT ONE TYPE OF INSERT DOES NOT FIT HIM IN THE TITANIUM TRAY AS WELL AS IN THE COCR TRAY - THIS IS THE SIGMA FB CURVED PLUS INSERT. CUSTOMER ASKING FOR CONFIRMATION OF THE COMPATIBILITY OF THE TWO ELEMENTS, I.E. SIGMA FB MODULAR TITANIUM TIBIAL TRAY (866022 ¿ 866029) IN COMBINATION WITH SIGMA FB CURVED PLUS INSERT (970420 ¿ 970485).

  Patient problems: Insufficient Information

  MAUDE report 15969091 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THEY WERE IMPLANTED IN (B)(6) 2001. REVISED DUE TO FAILURE OF THE METAPHYSEAL BONE OF THE TIBIA. THE SURGEON DOES NOT REQUIRE ANY FEEDBACK. DOI: (B)(6) 2001. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Osteolysis; Unspecified Tissue Injury

  MAUDE report 15923838 ↗
• InjuryJul 25, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PT HAD DONE WELL WITH PRIMARY TOTAL KNEE UNTIL EXPERIENCING A FALL AND THEN BECAME PAINFUL. SURGEON NOTED MILD LAXITY IN EXTENSION BUT MORE SIGNIFICANT INSTABILITY IN FLEXION. A POLY EXCHANGE WAS ATTEMPTED LOS OF EXTENSION WAS NOTED AND PATELLA WAS RIDING TOO LOW AS THE KNEE WAS FLEXED WHEN POLY THICKNESS WAS INCREASED TO STABILIZE FLEXION. ALL COMPONENTS WERE REMOVED AND A REVISION TOTAL KNEE WAS PERFORMED. TIBIA COMPONENT WAS FOUND TO BE LOOSE WHEN SURGEON BEGAN TO REMOVE. ULTIMATELY, A HINGED PROSTHESIS HAD TO BE UTILIZED TO STABILIZE THE FLEXION GAP AND ADDRESS THE JOINT LINE FOR PATELLAR POSITION. THERE WAS NO PATIENT HARM. INSTABILITY WAS NOT DUE TO WEAR, MALALIGNMENT, NOR UNDER SIZING OR OVER RESECTION. NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 15100025 ↗
• MalfunctionJul 22, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INSERT IS DIFFICULT TO ASSEMBLE TO TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15087618 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS PAIN DUE TO OVERSTUFFED TIBIAL IMPLANT. ISSUE WAS WITH THE SIZING OF THE IMPLANT. NO LOOSENING WAS PRESENT.

  Patient problems: Pain

  MAUDE report 14196663 ↗
• InjuryMar 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION TO ADDRESS STRESS REACTION. DATE OF IMPLANTATION: (B)(6) 2003. DATE OF REVISION: (B)(6) 2021 (RIGHT KNEE). TREATMENT: REVISION OF THE TIBIAL INSERT. CLINIC VISIT (B)(6) 2021: PATIENT PRESENTS WITH RIGHT KNEE PAIN, SWELLING, WARMTH, AND CREPITUS AFTER SEVERAL FALLS 20 YEARS STATUS POST BILATERAL KNEE IMPLANTATION. RADIOGRAPHIC IMAGES IDENTIFY AN ANTERIORLY DISTRACTED TIBIAL INSERT AND AN AREA OF ASYMPTOMATIC TIBIAL OSTEOLYSIS. PLAN IS MADE TO REVISE THE INSERT, AS THE TIBIAL AND FEMORAL COMPONENTS ARE WELL-FIXED AND INTACT. DOR: (B)(6) 2021: PATIENT RECEIVED A RIGHT KNEE INSERT REVISION TO TREAT PAIN AND LIMITED RANGE OF MOTION SECONDARY TO DISPLACEMENT OF THE TIBIAL INSERT. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED BLACK STAINED SYNOVIUM AND PERFORMED A COMPLETE SYNOVECTOMY. THE INSERT WAS DISPLACED ANTERIORLY. THE SURGEON NOTES THERE WAS NO WEAR OR PROBLEMS WITH THE LOCKING MECHANISM ON THE TRAY. THE TRAY WAS WELL-FIXED AND RETAINED. THE ISSUE WAS RESOLVED BY REPLACING THE OLD INSERT WITH A NEW INSERT THAT WAS ONE SIZE LARGER. THE INSERT SNAPPED INTO POSITION AND A ROM CHECK CONFIRMED IT WAS NO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall; Foreign Body Reaction; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 13658525 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THE PATIENT'S SIGMA PRIMARY KNEE COMPONENTS WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. DOI: (B)(6) 2005; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13167807 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OP INFECTION. THIS CASE IS FROM THE HEALTH AUTHORITY. IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY. DURING THE OPERATION, AN ANTERIOR MEDIAN INCISION OF THE RIGHT KNEE WAS SELECTED, ABOUT 10 CM IN LENGTH, THE SKIN AND SUBCUTANEOUS TISSUE WERE INCISED, AND THEN DISSOCIATED BILATERALLY ALONG THE DEEP SUBFASCIAL SPACE TO EXPOSE THE ANTERIOR KNEE JOINT AND THE RECTUS FEMORIS TENDON. INCISION OF THE SUPRAPATELLAR BURSA AND ARTICULAR CAPSULE ALONG THE MEDIAL SIDE OF THE RECTUS FEMORIS TENDON, THE MEDIAL BORDER OF THE PATELLA TO THE MEDIAL TIBIAL TUBERCLE, TURN THE PATELLA LATERALLY. RESECTION OF OSTEOPHYTES, SYNOVIUM, INFRAPATELLAR FAT PAD, MEDIAL AND LATERAL MENISCUS, ANTERIOR AND POSTERIOR CRUCIATE LIGAMENT; DISTAL FEMORAL OSTEOTOMY WAS PERFORMED BY INTRAMEDULLARY LOCALIZATION, VALGUS 7 DEGREE OSTEOTOMY. TIBIAL PLATEAU OSTEOTOMY WAS PERFORMED BY EXTRAMEDULLARY LOCALIZATION. VERTICAL RODS WERE PARALLEL TO THE LONG AXIS OF TIBIA WHEN VIEWED IN ANTEROPOSTERIOR AND LATERAL POSITION. THE INITIAL THICKNESS OF OSTEOTOMY WAS 10 MM, AND THE OSTEOTOMY PLANE WAS KEPT AT 3 DEGREE RETROVERSION. AFTER OSTEOTOMY, THE BALANCE OF THE EXTENSION GAP WAS TESTED. THE 10 MM GAP BL

  Patient problems: Unspecified Infection

  MAUDE report 12868764 ↗
• MalfunctionJun 2, 2021Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  INNER PACKING DEFORMED&UNSEALED. IT WAS REPORTED THAT DURING THE SURGERY OF LEFT TOTAL KNEE ARTHROPLASTY, CHECKED THE OUT-BOX, IT WAS COMPLETE GOOD, OPENED IT, NOTED THE 1ST INNER PACKING WAS DEFORMED BUT SEALED, OPENED THE 1ST INNER PACKING, NOTED THE 2ND INNER PACKING WAS ALSO DEFORMED AND UNSEALED AS THE PHOTOS SHOW. NO BACK-UP DEVICE ON SITE,SO USED IODOPHOR TO SOAK THE DEVICE, THEN IMPLANT INTO THE PATIENT. THE PATIENT IS STABLE AND IN HOSPITAL NOW. SURGERY DELAYED ABOUT 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11919231 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND POLY WEAR. A REVISION TO AN ATTUNE REVISION KNEE WITH SLEEVES, STEMS AND RP REVISION TIBIAL COMPONENT WAS DONE. NO FURTHER INFORMATION AVAILABLE. DOI: 20 YEARS AGO, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10278176 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. AN OLD SIGMA PS FEMUR WITH A CEMENTED STEM WAS REMOVED BUT NO PRODUCT NUMBERS WERE LEGIBLE ON THE IMPLANT. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9315630 ↗
• InjuryMay 31, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS MALPOSITIONED FEMORAL COMPONENT AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2018. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8658268 ↗
• InjuryDec 12, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS REVISED TO ADDRESS SUBSIDENCE. IT WAS ALSO STATED THAT THERE WAS A TIBIAL CYST AND MEDIAL WEAR. DOI: (B)(6) 2013; DOR: (B)(6) 2017; UNKNOWN KNEE.

  Patient problems: Cyst(s)

  MAUDE report 7108863 ↗
• InjuryOct 13, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE, COMPETITOR CEMENT WAS USED. FEMORAL COMPONENT WAS NOT LOOSE BUT ALSO REVISED DUE TO SURGEON PREFERENCE. PATELLA WAS NOT LOOSE.

  Patient problems: No Information

  MAUDE report 6947379 ↗
• InjurySep 29, 2017Malposition of Device; Malposition of Device

  THE PATIENT WAS REVISED TO ADDRESS IMPLANT POSITION AND OSTEOLYSIS. IT STATED THAT THE SIGMA KNEE WAS EXPLANTED.

  Patient problems: Osteolysis

  MAUDE report 6904581 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K882234, K884796. One submission often covers many models, so check the product and lot details in each record.

• Z-3099-2011 · Jun 28, 2011 · Terminated
  PFC Sigma Round Dome Patella 38 MM 3 Peg Device is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacryla
• Z-1338-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 4, 12.5 mm; Ref 98-4154.
• Z-1336-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 4, 8.0 mm; Ref 98-4152.
• Z-1340-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 5, 8.0 mm; Ref 98-4157.
• Z-1339-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 5, 10.0 mm; Ref 98-4158.
• Z-1346-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 15.0 mm; Ref 98-4626.
• Z-1343-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 4, 12.5 mm; Ref 98-4618.
• Z-1332-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 1, 10.0 mm; Ref 98-4031.
• Z-1333-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 12.5 mm; Ref 98-4144.
• Z-1334-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 10.0 mm; Ref 98-4143.
• Z-1345-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 8.0 mm; Ref 98-4623.
• Z-1335-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 8.0 mm; Ref 98-4142.
• Z-1344-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 10.0 mm; Ref 98-4624.
• Z-1337-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 3, 17.5 mm; Ref 98-4151.
• Z-1342-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 3, 12.5 mm; Ref 98-4610.

…and 1 more.