P.F.C. SIGMA 86-6023Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295216780), received between Jul 24, 2017 and May 19, 2025 — classified as 25 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (14 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF TIBIAL PART OF A SIGMA KNEE-TEP. THERE WAS A LOOSENING BETWEEN THE METAL-CEMENT INTERFACE AT THE TIBIA.

  Patient problems: Insufficient Information

  MAUDE report 22043763 ↗
• InjuryMar 6, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY, REQUIRING EXTENSIVE DEBRIDEMENT. EXTENSIVE BONE EROSION WAS NOTED ON THE MEDIAL AND LATERAL FEMORAL CONDYLES AS WELL AS ALONG THE MEDIAL TIBIAL PLATEAU REQUIRING BONE GRAFTING TO CORRECT. GRANULATION TISSUE INDICATIVE OF LOOSENING WAS NOTED. THE FEMORAL AND TIBIAL SIDES WERE NOTED TO BE LOOSE - INTERFACE NOT IDENTIFIED. THE PATELLA WAS REMOVED AND UNDERNEATH SMALL CYSTS WERE IDENTIFIED AND REMOVED BEFORE REPLACING. A FRACTURE OF THE FEMORAL STEM AND THE CONNECTING SCREW OCCURRED WITHOUT TRAUMA. THE CONNECTING SCREW BETWEEN THE FEMORAL SHIELD AND THE FEMORAL SHAFT IS AFFECTED. THE REVISION WENT SMOOTHLY.

  Patient problems: Bone Notching; Pocket Erosion; Unspecified Tissue Injury

  MAUDE report 21536909 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HCP SENT A MEDICAL INFO REQUEST TO TEAM: "I HAVE A PATIENT IN THE CLINIC WHO HAS DEVELOPED SYMPTOMS SINCE SEVERAL WEEKS AFTER IMPLANTATION OF A PFC MODULAR PLUS PROSTHESIS. SURGICAL DATE (B)(6) 2008: PFC MODULAR RIGHT KNEE: FEMUR CEMENTED, SIZE 4, TIBIA CEMENTED, SIZE 3, PLATEAU HEIGHT 10 MM STABILIZED; PATELLUM SHAPING. THE PATIENT NOW PRESENTS AND THE IMAGES SHOW THE INLAY AS WORN/DEFECTIVE WITH A DEFECT ON THE DORSAL MEDIAL TIBIAL CONSOLE AND VENTRAL SUBLUXATION OF THE TIBIA TO THE FEMUR. IT IS CLEAR THAT THERE WILL BE A CERTAIN AMOUNT OF METALLOSIS WITH A DORSALLY RUBBED TIBIAL COMPONENT. AS THE MANUFACTURER, IS IT STILL PERMISSIBLE TO CHANGE THE INLAY ALONE IN THE CASE OF A DORSALLY IMPAIRED TIBIAL COMPONENT?".

  Patient problems: Foreign Body Reaction; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 18825863 ↗
• MalfunctionFeb 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT REPORTED: "I AM CURRENTLY LIVING IN (B)(6). IN (B)(6) 2021, I HAD SURGERY ON BOTH MY RIGHT AND LEFT KNEES. THE SURGEON RECOMMENDED IT BECAUSE HE CONNECTED AND HAS AN AGREEMENT WITH THE IMPORTING COMPANY, AND WE AGREED TO USE JOHNSON & JOHNSON'S IMPLANTS AS YOUR COMPANY IS KNOWN FOR ITS WORLD-CLASS PRODUCTS AND STELLAR REPUTATION. MY CONDITION SINCE THE SURGERY HAS BECOME WORSE THAN IT WAS BEFORE. NOWADAYS, ESPECIALLY THE RIGHT ONE, I GET TIRED AFTER WALKING A SHORT DISTANCE AND WOULD NEED TO LEAN ON SOMEONE. CURRENTLY, I AM EXPERIENCING EXCRUCIATING PAIN IN BOTH OF MY KNEES THAT HAVE BECOME SWOLLEN. PLEASE NOTE THAT BEFORE THE SURGERY, I NEVER EXPERIENCED THESE SYMPTOMS. THE SURGEON WHO PERFORMED THE PROCEDURE AND THE COMPANY IS NOT PROVIDING A LOGICAL EXPLANATION FOR WHY I AM EXPERIENCING PAIN."

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 18649262 ↗
• MalfunctionFeb 5, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT REPORTED: "I AM CURRENTLY LIVING IN SYRIA. IN (B)(6) 2021, I HAD SURGERY ON BOTH MY RIGHT AND LEFT KNEES. THE SURGEON RECOMMENDED IT BECAUSE HE CONNECTED AND HAS AN AGREEMENT WITH THE IMPORTING COMPANY, AND WE AGREED TO USE JOHNSON & JOHNSON'S IMPLANTS AS YOUR COMPANY IS KNOWN FOR ITS WORLD-CLASS PRODUCTS AND STELLAR REPUTATION. MY CONDITION SINCE THE SURGERY HAS BECOME WORSE THAN IT WAS BEFORE. NOWADAYS, ESPECIALLY THE RIGHT ONE, I GET TIRED AFTER WALKING A SHORT DISTANCE AND WOULD NEED TO LEAN ON SOMEONE. CURRENTLY, I AM EXPERIENCING EXCRUCIATING PAIN IN BOTH OF MY KNEES THAT HAVE BECOME SWOLLEN. PLEASE NOTE THAT BEFORE THE SURGERY, I NEVER EXPERIENCED THESE SYMPTOMS. THE SURGEON WHO PERFORMED THE PROCEDURE AND THE COMPANY IS NOT PROVIDING A LOGICAL EXPLANATION FOR WHY I AM EXPERIENCING PAIN."

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 18639109 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS REMOVED AND REVISED DUE TO PAIN AND SWELLING IN THE FEMUR AND TIBIA. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 16598882 ↗
• InjuryFeb 14, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  RIGHT KNEE REVISION FOR ASEPTIC TIBIAL LOOSENING AT THE CEMENT IMPLANT INTERFACE WITH NOT CEMENT FROM DEPUY. DOI: (B)(6) 2019. DOR: (B)(6) 2023. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16371399 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A NICKEL ALLERGY AND REACTED TO THE IMPLANT. DR. REMOVED THE IMPLANT AND REPLACED WITH AESCULAP. DOI- UNKNOWN; DOR- (B)(6) 2022; AFFECTED SIDE- LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15979447 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO INSTABILITY AND PAIN. DOI: UNKNOWN. DOR: (B)(6) 2022. LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15564194 ↗
• InjurySep 1, 2022Naturally Worn; Naturally Worn

  HCP REPORTED TO BFARM: "KNEE TEP RIGHT SIDE (B)(6) 2001 IN NEUSTADT BECAUSE OF VARUS GONARTHROSIS. SINCE THE BEGINNING OF THE YEAR 2022 THERE IS AGAIN PAIN IN THE RIGHT KNEE JOINT, SINCE THEN ALSO INCREASING BOW-LEG DEFORMITY. THE PATIENT IS ABLE TO WALK 200 METERS WITHOUT ANY AIDS UNDER PAIN. CLIMBING STAIRS IS LABORIOUS. OBESE. BMI 30. KNEE TEP LEFT (B)(6) 2001. RADIOLOGICAL PE WEAR AND LOOSENING OF TIBIA. REPLACEMENT SURGERY RIGHT KNEE ON (B)(6) 2022."

  Patient problems: Pain

  MAUDE report 15339481 ↗
• InjurySep 1, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  HCP REPORTED TO BFARM: "KNEE TEP RIGHT SIDE (B)(6) 2001 IN NEUSTADT BECAUSE OF VARUS GONARTHROSIS. SINCE THE BEGINNING OF THE YEAR 2022 THERE IS AGAIN PAIN IN THE RIGHT KNEE JOINT, SINCE THEN ALSO INCREASING BOW-LEG DEFORMITY. THE PATIENT IS ABLE TO WALK 200 METERS WITHOUT ANY AIDS UNDER PAIN. CLIMBING STAIRS IS LABORIOUS. OBESE. BMI 30. KNEE TEP LEFT (B)(6) 2001. RADIOLOGICAL PE WEAR AND LOOSENING OF TIBIA. REPLACEMENT SURGERY RIGHT KNEE ON (B)(6) 2022."

  Patient problems: Pain

  MAUDE report 15339426 ↗
• MalfunctionAug 3, 2022Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE STERILE PACKED INSIDE PLASTIC BOX WAS STUCK TO THE OUTSIDE PLASTIC BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157722 ↗
• InjuryAug 10, 2021Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  THE PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. THE PATIENT PRESENTED WITH A SIGMA KNEE THAT WAS DONE ABOUT 15 YEARS AGO. PATIENT COULD NOT PROVIDE THE EXACT DATE. IT WAS REPORTED THAT IT WAS REPLACED WITH A MODULAR PLUS SIGMA TIBIA WITH A STEM AND 10 MM MEDIAL AUGMENT. THE SURGEON THEN INSERTED A CURVED PLUS TIBIAL INSERT. ALL COMPONENTS WERE WELL FIXED AND KNEE WAS STABLE. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: 2005, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12303251 ↗
• InjuryJun 22, 2021Loss of or Failure to Bond; Use of Device Problem; Loss of or Failure to Bond; Use of Device Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF TIBIAL COMPONENT AND PATELLA IN A CEMENT TO IMPLANT INTERFACE. IT WAS REPORTED THAT IT WAS LOOSE TIBIAL TRAY VARUS. IT WAS REPORTED THAT THE TIBIAL TRAY ONLY HAD CEMENT ATTACHED TO LATERAL SIDE. ALL IMPLANTS WERE REVISED. A COMPETITOR CEMENT WAS USED. NO SURGICAL DELAY. DOI: 2001; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12041924 ↗
• InjuryNov 10, 2020Unintended Movement; Unintended Movement

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS ASEPTIC. LOOSENING. DATE OF IMPLANTATION: (B)(6) 2002. DATE OF REVISION: (B)(6) 2020. (LEFT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, AND TIBIAL INSERT WERE REVISED; PATELLA RETAINED. UPDATE: MEDICAL RECORDS RECEIVED AD 21 OCT 2020 WERE REVIEWED ON 27 OCT 2020 BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. PRIMARY OPERATIVE NOTES (B)(6) 2002 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2020 INDICATES THE PATIENT RECEIVED AN ADDITIONAL LEFT TOTAL KNEE REVISION DUE TO SIGNIFICANT POLYETHYLENE WEAR AND VARUS COLLAPSE OF THE KNEE, PAIN AND DECREASED FUNCTION. THE INSERT WAS REMOVED AND INDICATED TO HAVE SIGNIFICANT WEAR. THE TIBIAL AND FEMORAL COMPONENTS WERE NOTED TO BE WELL FIXED BUT ALSO REVISED. SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10817196 ↗
• InjuryJul 22, 2020Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  LOOSE TIBIAL TRAY. LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10307556 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS UNSTABLE KNEE. THEY DO NOT KNOW WHEN OR WHERE THE PRIMARY SURGERY WAS PERFORMED. COULD ONLY SEE A LOT NUMBER ON THE TIBIA. THE FEMUR LOOKED LIKE A SIZE 3 SIGMA PS RIGHT FEMUR. NO LOT NUMBER COULD BE SEEN. THE INSERT WAS FIXED BEARING BUT NO NUMBERS COULD BE SEEN. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10246471 ↗
• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS ASEPTIC LOOSENING DATE OF IMPLANTATION: (B)(6) 1991. DATE OF REVISION: (B)(6) 2019. (LEFT KNEE).

  Patient problems: No Code Available

  MAUDE report 9607058 ↗
• InjurySep 19, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS ANTERIOR KNEE PAIN DUE TO FALL AND LOOSENING OF THE PATELLAR COMPONENT & TIBIAL TRAY AT THE IMPLANT TO CEMENT INTERFACE. DEPUY CEMENT MANUFACTURER WAS USED. X-RAY SHOWED FOX OF PROXIMAL POLE OF PATELLA. TIBIAL COMPONENT WITH STEM AND A NEW PATELLA WAS IMPLANTED. THE INSERT HAD BEEN EXCHANGED PREVIOUSLY ON (B)(6) 2016. DOI: (B)(6) 2011 (TIBIAL TRAY); DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9087552 ↗
• MalfunctionNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE BONE TO CEMENT INTERFACE.

  Patient problems: No Code Available

  MAUDE report 8038297 ↗
• InjurySep 17, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS FROM COMPETITOR. PATIENT HAD A TOTAL KNEE ARTHROPLASTY DONE ON THE LEFT SIDE ON 5/20/15. DOI: (B)(6) 2015; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7880804 ↗
• InjuryJul 25, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AND TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER USED WAS UNKNOWN. DOI: (B)(6) 2003; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7718716 ↗
• InjuryMay 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE WOUND PAIN, IMPROVED AFTER MULTIPLE TREATMENT MEASURES AFTER SURGERY, CERTAINLY RELATED TO SURGERY. DOI:UNKNOWN DOR: (B)(6) 2018 UNKNOWN AFFECTED SIDE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7514828 ↗
• InjuryFeb 23, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF FEMUR AND TIBIA AT BONE/CEMENT AND CEMENT/IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: 2001; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7291943 ↗
• InjuryFeb 22, 2018Malposition of Device; Malposition of Device

  DER STATES THAT SURGEON REVISED RIGHT TOTAL KNEE APPROXIMATELY 14 YEARS AFTER PLACEMENT. SURGEON STATES TIBIAL TRAY WAS PLACED IN EXTREME VALGUS AND STATES THAT IS THE CAUSE OF THE FAILURE. PATELLA WAS RETAINED BUT FEMORAL, TIBIAL TRAY AND INSERT WERE REMOVED. DOI - APPROXIMATELY 14 YEARS, DOR - (B)(6) 2018, RIGHT KNEE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7288520 ↗

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-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-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.
• 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-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-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-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-1341-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 6, 15.0 mm; Ref 98-4198.
• 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-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-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-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-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-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.

…and 1 more.