P.F.C. SIGMA 96-0101Recalls & reported problems

Summary

The FDA's MAUDE database contains 172 adverse event reports that list this exact device (DI 10603295232612), received between Aug 25, 2017 and Sep 29, 2026 — classified as 162 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (14 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 25 most recent of 172 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50934378 ↗
• InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMPONENTS WERE TAKEN OUT DUE TO INFECTION AND ANTIBIOTIC SPACER WAS PUT IN. DOI: (B)(6) 2014, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 25841975 ↗
• InjuryJul 15, 2026Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF PATELLA. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25824643 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT INFECTED KNEE WITH LOOSENING. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25070937 ↗
• InjuryMar 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT HAD PATELLAR CLUNK IN TC3 CONSTRUCT. PATELLA TISSUE WAS REVISED. POLY WAS SWAPPED FROM 17.5 TO 20. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24524413 ↗
• 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. (B)(6)). REVISION: (B)(6) 2026 (DR. (B)(6)). SIDE: LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 24483197 ↗
• InjuryMay 6, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF PATELLA COMPONENT WITH POLY EXCHANGE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21969990 ↗
• InjuryJan 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE INSERT HAD A POSTERIOR MEDIAL CRACK IN IT AND PATELLA COMPONENT WAS LOOSE. THE LOOSENING INTERFACE OF THE PATELLA COMPONENT IS CEMENT/IMPLANT. BOTH WERE EXCHANGED FOR NEW IMPLANTS. THERE WAS NO SURGICAL DELAY AND ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2008. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21257468 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HAVING SLIGHT INSTABILITY. THE PATELLA AND POLY EXCHANGE WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES DUE TO SURGERY AND THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21251700 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS: CLINICAL ADVERSE EVENTS RECEIVED FOR CONTINUED PAIN, PINCHING SENSATION DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: REMOTE POSSIBILITY. DATE OF EVENT: 8/OCT/2024 DATE OF IMPLANT: NO INFORM.ATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: SURGICAL EXPLORATION OF THE FEMUR AND DEBRIDEMENT OF THE FAT PAD. DEPUY COMPONENTS USED IN PROCEDURE WITHOUT DATE OF REVISION: CATALOG ID: 129433130, LOT ID: 9744770, COMPONENT TYPE: TIBIAL, DESCRIPTION: MBT CEMENTED KEEL SZ 3. CATALOG ID: 940023, LOT ID: J50C75, COMPONENT TYPE: FEMORAL, DESCRIPTION: SIGMA FEM C/RET POROCOAT SZ 3 RT. CATALOG ID: 960101, LOT ID: D20101506, COMPONENT TYPE: PATELLAR, DESCRIPTION: SIGMA PATELLA OVAL DOME 3 PEGGED 35MM. CATALOG ID: 3322020, LOT ID: 9524034, COMPONENT TYPE: CEMEN,T DESCRIPTION: SMART SET BONE CEMENT 20G. CATALOG ID: 3322020, LOT ID: 9448053, COMPONENT TYPE: CEMENT, DESCRIPTION: SMART SET BONE CEMENT 20G. CATALOG ID: 196192034, LOT ID: 9137529, COMPONENT TYPE: INSERT, DESCRIPTION: AOX CVD RP TIBIAL INSERT SZ 3 17.5MM. THE PATIENT STATUS POST: RIGHT KNEE REPLACEMENT/REVISION KNEE REPL

  Patient problems: Discomfort; Numbness; Pain; Paresthesia

  MAUDE report 20558789 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION OF A TOTAL KNEE REPLACEMENT. THE PATIENT UNDERWENT THE ORIGINAL PROCEDURE WITH A SIGMA PFC TRAY ABOUT FOURTEEN (14) MONTHS AGO. THE TRAY WAS REVISED FOR TIBIO TRAIN LOOSENING. THE SURGEON INDICATED THIS WAS BECAUSE OF LYSIS UNDER THE CEMENT MANTLE; LYSIS WAS NOT WAS NOT SEEN BETWEEN THE IMPLANT AND THE CEMENT, BUT THE SURGEON THOUGHT THERE WAS LIGHT BETWEEN THE CEMENT AND THE BONE. THE SURGEON DID NOT THINK THAT THIS IS AN IMPLANT RELATED ISSUE. THE SURGEON NOTED THAT THE CEMENT USED WAS NOT DEPUYSYNTHES CEMENT.

  Patient problems: Osteolysis

  MAUDE report 20440332 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: ON (B)(6) 2017, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20401203 ↗
• InjuryOct 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT WAS REVISED DUE TO EXCESSIVE POLY WEAR. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20397474 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE DEVICE (RELATEDNESS): DEFINITELY NOT. PROCEDURE (RELATEDNESS): POSSIBLY. DATE OF EVENT: 28/AUG/2024 . DATE OF IMPLANT: INFORMATION NOT PROVIDED. DATE OF REVISION: INFORMATION NOT PROVIDED. DEVICE LOCATION: INFORMATION NOT PROVIDED. TREATMENT/IMPACT: PE

  Patient problems: Pulmonary Embolism

  MAUDE report 20290245 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR SPIN OUT, DEVICE AND PROCEDURE(RELATEDNESS), DEVICE RELATED: NOT RELATED, PROCEDURE RELATED: NOT RELATED, DATE OF EVENT: 13/AUG/2024. DEVICE LOCATION: LEFT. ADDITIONAL EVENT INFORMATION: ON 08/29/2024 MEDICAL RECORDS NOTE THE PATIENT HAS A HISTORY OF KNEE PAIN IN THE PATELLOFEMORAL LIGAMENT MEDIAL TO THE PATELLA. A SMALL BAND OF SCAR TISSUE IS PALPABLE. RADIOGRAPHS NOTE A WELL -PLACED ROTATING PLATFORM KNEE. THE SURGEON IMPRESSION IS OF A FIBROUS BAND OF TISSUE THAT IS BOTHERING THE PATIENT. THE SURGEON INJECTED THE KNEE WITH DEXAMETHASONE AND LIDOCAINE TO ADDRESS PAIN.

  Patient problems: Adhesion(s); Fibrosis; Pain

  MAUDE report 20233001 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DRAINAGE POST SURGERY AND ELEVATED LABS INDICATIVE OF INFECTION. COMPONENTS WERE REMOVED AND A SPACER WAS MADE UTILIZING LPS COMPONENTS. NO DELAY WAS EXPERIENCED NOR PATIENT HARM OCCURRED. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19828697 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024 DATE OF EVENT: (B)(6) 2024. (RIGHT KNEE). TREATMENT: I&D.

  Patient problems: Unspecified Infection

  MAUDE report 19228721 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  MEDICAL RECORDS WERE RECEIVED: CLINIC NOTE DATED (B)(4) 2024; FOLLOW-UP FOR PATELLA FRACTURE. THE PATIENT HAS FULL STRENGTH RETURNED AND THE KNEE IMMOBILIZED IS REMOVED. X-RAYS IDENTIFY A STABLE PATELLA FRACTURE WITH MINIMAL OSTEOLYTIC CHANGES TO THE PATELLA THAT WILL NOT REQUIRE ADDITIONAL TREATMENT AT THIS TIME. AN ACTIVITY IS CREATED TO UPDATE THE PATELLA WITH PATIENT CODE OSTEOLYSIS, AS THE LYTIC CHANGES ARE ONLY NOTED ON THE PATELLA SECONDARY TO THE FRACTURE.

  Patient problems: Bone Fracture(s); Osteolysis

  MAUDE report 19179819 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR GI BLEED. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2024. (RIGHT KNEE). TREATMENT: FOUR UNITS OF BLOOD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19142608 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID :(B)(6). STUDY NO :(B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: 29 FEB 2024. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL, TIBIAL, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 18874199 ↗
• InjuryMar 7, 2024Off-Label Use; Off-Label Use

  WE IMPLANTED AN ATTUNE KNEE PROSTHESIS WITH A SIGMA PATELLA BUTTON. AS SOON AS WE IDENTIFIED THE DISCREPANCY, THE THEATRE TEAM MADE CONTACT WITH YOU TO CONFIRM IF THE PATELLA BUTTON USED WAS COMPATIBLE WITH THE KNEE PROSTHESIS IMPLANTED, TO WHICH YOU CONFIRMED. PATIENT WAS TAKE BACK TO THEATRE THE FOLLOWING DAY TO REPLACE A COMPONENT OF THEIR KNEE REPLACEMENT SYSTEM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18856000 ↗
• InjuryMar 1, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO SEPTIC LOOSENING OF IMPLANTS AT UNKNOWN INTERFACE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN DOR- (B)(6) 2024 AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 18818592 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6); STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR FOOT DROP. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2023, (LEFT KNEE). TREATMENT: PATIENT FITTED WITH AFO.

  Patient problems: Nerve Damage

  MAUDE report 18703497 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Muscular Rigidity

  MAUDE report 18160037 ↗
• MalfunctionNov 13, 2023Fracture; Fracture

  CLINICAL ADVERSE EVENT RECEIVED FOR DISTAL POLE OF PATELLA FX WITH MILD DISPLACEMENT. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022; DATE OF EVENT: (B)(6) 2023; (RIGHT KNEE). TREATMENT: NONE.

  Patient problems: Insufficient Information

  MAUDE report 18117997 ↗