P.F.C. SIGMA 96-0112Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295232681), received between Aug 3, 2017 and Aug 30, 2023 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO ANTERIOR KNEE PAIN. THE PATELLA IMPLANT HAD BECOME LOOSE. THERE WAS WEAR ON THE PATELLA MEDIALLY DUE TO PATIENT'S PATELLA TENDON TRACKING LATERALLY. A REVISION SURGERY WAS PERFORMED AND THE 38 SIGMA PATELLA WAS REMOVED. THE CEMENT (UNKNOWN MANUFACTURER) WAS ATTACHED WELL TO THE PATELLA IMPLANT AND IN THE PATELLA DRILL HOLES. DUE TO LATERAL PATELLA TRACKING ISSUES AND REMNANT OF NATURAL PATELLA, A NEW PATELLA IMPLANT WAS NOT IMPLANTED. DOI: (B)(6) 2021. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17652271 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT STATED THAT "I HAD BILATERAL KNEE REPLACEMENTS PERFORMED (B)(6) 2011 WITH SIGMA IMPLANTS. MY ORTHOPEDIC SURGEON IN (B)(6) SAID THE KNEES WOULD LAST 15-20 YEARS. HAVING SIGNIFICANT PAIN IN BOTH KNEES WHILE CYCLING PROMPTED A VISIT TO DR. ON (B)(6) 2021 WHERE HE INFORMED ME THAT THE HARDWARE HAS COME LOOSE INDICATING A REVISION IS NEEDED. THIS IS WELL SHORT OF THE 15-20 YEARS LIFESPAN OF THE SURGERY. I HAD A CYCLING GOAL TO DO RAAM (RACE ACROSS AMERICA) AND HAD TO CANCEL A QUALIFIER IN LATE AUGUST IN UTAH. I WAS HOPING TO BECOME THE FIRST 70+ YEAR OLD RIDER TO BE AN OFFICIAL FINISHER. NOW DUE TO REVISION IN THE KNEES, I'LL HAVE TO WAIT AT LEAST 2 YEARS.

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

  MAUDE report 16536347 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A COMPLETE REVISION WAS DONE SINGLE STAGE. THERE WAS NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14985987 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION OF RIGHT TOTAL KNEE I & D WASHOUT REMOVAL OF IMPLANTS. ANTIBIOTIC CEMENT SPACERS. DOI- (B)(6) 2017; DOR- (B)(6) 2022; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13964681 ↗
• InjuryMar 30, 2022Naturally Worn; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE TO ADDRESS POLYETHYLENE WEAR. DATE OF IMPLANTATION: (B)(6) 2002, DATE OF REVISION: (B)(6) 2022, (LEFT KNEE). TREATMENT: REVISION OF TIBIAL INSERT AND PATELLA COMPONENTS.

  Patient problems: Insufficient Information; Pain; Synovitis

  MAUDE report 13950463 ↗
• InjuryDec 29, 2021Fracture; Naturally Worn; Fracture; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT KNEE TO ADDRESS POLYETHYLENE WEAR. DATE OF IMPLANTATION: (B)(6) 2002; DATE OF REVISION: (B)(6) 2021; (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT AND PATELLA COMPONENTS. PRODUCT DETAILS: CATALOG: 129434130 , LOT: U4FER1007, DESCRIPTION: MBT POROCOAT KEEL SZ 3. CATALOG: 960053 , LOT: 286624, DESCRIPTION: SIGMA FEM POST/STAB CEMENTED RT SZ 3. CATALOG: 960112 , LOT: 1022501, DESCRIPTION: SIGMA PATELLA ROUND DOME 3 PEGGED 38.0MM. CATALOG: 962131 , LOT: 77005A, DESCRIPTION: SIGMA TIBIAL INSERT RP POST/STAB SZ 3 10MM. CATALOG: 545033000 , LOT: V4CC94000, DESCRIPTION: ENDURANCE BONE CEMENT 40G. CATALOG: 545033000 , LOT: V4CC94000, DESCRIPTION: ENDURANCE BONE CEMENT 40G.

  Patient problems: Insufficient Information; Joint Laxity; Pain; Synovitis

  MAUDE report 13111345 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFFNESS. PATIENT WAS ONLY ABLE TO EXTEND HER KNEE APPROXIMATELY SEVENTY DEGREES, ACCORDING TO THE SURGEON WHO PERFORMED THIS PATIENT'S PRIMARY AND REVISION PROCEDURE. THE PATIENT'S PRIMARY SIGMA COMPONENTS WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. DOI: (B)(6) 2008; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 12373187 ↗
• InjuryAug 3, 2021Naturally Worn; Naturally Worn

  CLINICAL ADVERSE EVENT RECEIVED FOR POLY WEAR AND SPIN OUT. SEVERE POSTERIOR TIBIAL INSERT WEAR AND EROSION WITH EROSION AND WEAR OF TIBIAL POST. ALSO SEVERE PATELLAR WEAR WITH DELAMINATION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. (B)(6) 2021 - THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO INCREASING PAIN, FEELING OF A ¿LOCKED KNEE¿ AND DIFFICULTY AMBULATING. PRE-REVISION THE KNEE WAS DEMONSTRATING SUBLUXATION ¿ POSSIBLY FULL ANTERIOR DISLOCATION OF THE FEMUR ON THE TIBIA. UPON ENTERING THE JOINT, THERE WAS CLEAR LEAKAGE OF LYMPH FLUID. SOME METALLOSIS STAINING OF THE SYNOVIUM NOTED. THE PATELLA COMPONENT WAS NOTED TO BE WORN AND DELAMINATED. THE INSERT COMPONENT WAS WORN WITH EROSIONS AS WELL. THE INSERT AND PATELLA COMPONENTS WERE REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DATE OF IMPLANT: (B)(6) 2003; DATE OF EVENT: (B)(6) 2018; DATE OF REVISION: (B)(6) 2021 ; (LEFT KNEE). TREATMENT: REVISION OF INSERT AND PATELLA.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Synovitis

  MAUDE report 12267038 ↗
• InjuryJul 6, 2021Use of Device Problem; Use of Device Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A PRIMARY RIGHT KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY PRODUCTS AND CEMENT X 2 WERE UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS PAIN, ADHESIONS, PATELLA MALTRACKING, AND MISPOSITIONING OF BOTH THE TIBIAL TRAY AND FEMORAL COMPONENT. THE SURGEON NOTED A FAIR AMOUNT OF FLUID IN THE KNEE, MINOR BONE LOSS THE FEMUR, AND VERY RED SUBCUTANEOUS TISSUE. NO EVIDENCE OF INFECTION. THE TIBIAL TRAY WAS NOTED TO BE SIGNIFICANTLY PLACED POSTERIORLY AS WELL AS SLIGHTLY INTERNALLY ROTATED TO THE TIBIAL TUBERCLE AND THE FEMORAL COMPONENT WAS ALSO SLIGHTLY INTERNALLY ROTATED. THE PATELLAR COMPONENT WAS STABLE. IT WAS FELT THE JOINT LINE HAD BEEN RAISED SIGNIFICANTLY BASED ON EVALUATION OF THE X-RAYS AS WELL AS OTHER EVIDENCE INTRA-OPERATIVELY. TO CORRECT THE PROBLEMS THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED WITH THE GOAL OF SALVAGING THE PATELLAR COMPONENT. THE SURGEON RELEASED ADHESIONS IN THE SUPRAPATELLAR POUCH AND LATERAL GUTTER AND ATTEMPT TO MOBILIZE THE PATELLA LATERALLY. THE RESULT WAS A PATELLAR THAT TRA

  Patient problems: Adhesion(s); Pain

  MAUDE report 12122938 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL IMPLANT EXPLANTED, CONVERT TO ANTIBIOTIC SPACER DUE TO INFECTION. POLY INSERT CHANGED ON (B)(6) 2019 FROM PREVIOUS INFECTION. DOI: (B)(6) 2019 ALL EXPLANTED PRODUCTS, DOI: (B)(6) 2019 TIBIAL INSERT, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11917919 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. CONVERT TO ANTIBIOTIC SPACER. A DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11820281 ↗
• MalfunctionJan 19, 2021Naturally Worn; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE PATELLOFEMORAL JOINT REPLACEMENT DATE OF IMPLANTATION: (B)(6) 2009; DATE OF REVISION: (B)(6) 2020; (LEFT KNEE). TREATMENT: FEMORAL AND PATELLAR COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 11193095 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. A 2ND STAGE REPLACEMENT WAS PERFORMED WHEN INFECTION WAS GONE. ORIGINAL IMPLANT DATE IS UNKNOWN. NO SURGICAL DELAY IS NOTED. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10485054 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUED TO HAVE ISSUES WITH INSTABILITY AND PAIN, AS WELL AS ADHESION. DOI: (B)(6) 2019. DOR: UNKNOWN LEFT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 9752250 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A INFECTED LEFT KNEE. LPS POLY INSERT WAS EXCHANGED. WASH OUT AND I&D WERE PERFORMED IT WAS REPORTED AT (B)(4). REVISED REPORT: PATIENT WENT ON TO HAVE A LEFT ABOVE KNEE AMPUTATION. ADDING IMPLANTS TO REPORT THAT WERE TAKEN OUT AT TIME OF AMPUTATION ON (B)(6) 2019. THESE WERE ORIGINALLY IMPLANTED (B)(6) 2019 AND (B)(6) 2019. DOI: (B)(6) 2019, (B)(6) 2019 AND (B)(6) 2019 (LPS UNIV TIB HIN INS XSM 16MM); DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8864555 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE SECOND LEFT KNEE REVISION, PATIENT SUSTAINED A LEFT POPLITEAL DVT ON (B)(6) 2018, TREATED WITH BLOOD THINNER. HE THEN PRESENTED WITH AN UNKNOWN RASH WITH 4 SMALL PULMONARY EMBOLI.

  Patient problems: Embolism; Rash; Thrombosis

  MAUDE report 8487687 ↗
• InjuryJan 31, 2019Fracture; Fracture

  IT WAS REPORTED THAT PATIENT REPORTEDLY HAD A LEFT TKR PERFORMED AT (B)(6) HOSPITAL IN (B)(6) SOMETIME IN 2005 TO 2007. KNEE DONE THEN WAS A CR RP SIGMA. OVERTIME PATIENT DEVELOPED PATELLA PAIN. PATIENT ALSO HAD HISTORY OF PATELLA FRACTURE IN 2002 TIMEFRAME. X-RAY PRIOR TO REVISION SHOWED EXTENSIVE PATELLA OSTEOPHYTE. OSTEOPHYTE REMOVED AND A NEW PATELLA IMPLANTED. DOI: 2005; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8292736 ↗
• InjuryNov 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL DER STATES THAT REVISION OF DEPUY TIBIAL AND INSERT COMPONENTS DUE TO OSTEOLYSIS.

  Patient problems: Osteolysis

  MAUDE report 7063807 ↗
• InjuryNov 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7006068 ↗
• InjuryAug 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS ADDRESS TO REVISED INFECTION. PATIENT REPORTEDLY GOT INFECTED IN A FOOT AND WENT TO THE KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 6764254 ↗