P.F.C. SIGMA 1581-23-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295064244), received between Jul 21, 2017 and Oct 25, 2024 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

51 other recalls cover devices cleared under the same FDA submission (K033272, K241000); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RIGHT KNEE TIBIAL INSERT WAS REVISED ON (B)(6) 2024 DUE TO UNSTABLE KNEE. DATE OF IMPLANT UNKNOWN

  Patient problems: Joint Laxity

  MAUDE report 20531729 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. LINER WAS EXCHANGED. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20450852 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE CLEANING AND RE-REVISION SURGERY AFTER THE CONFIRMATION OF INFECTION. THIS PC REPORTS THE PAIN AND INFECTION AFTER THE REVISION SURGERY. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED. IT IS ALSO UNKNOWN WHETHER THE IMPLANTS USED IN THE PRIMARY SURGERY ARE JJ PRODUCTS OR NOT. ON (B)(6) 2022, THE REVISION SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. THE REASON FOR THE REVISION IS UNKNOWN. AFTER THE REVISION SURGERY, ON (B)(6) 2023, THE PATIENT CAME TO THE HOSPITAL COMPLAINING OF THE SUDDEN KNEE PAIN, AND THE INFECTION WAS CONFIRMED. NO FURTHER INFORMATION IS AVAILABLE. DOI; (B)(6) 2022.. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17116832 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO MRSSA. I AND D AND POLY EXCHANGE WERE PERFORMED. DOI: (B)(6 2015. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16806650 ↗
• MalfunctionMar 10, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE POLYETHYLENE DOES NOT FIT THE TIBIAL COMPONENT. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521752 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO POLYETHYLENE WEAR, NO MALPOSITION, COMPONENTS WERE NOT UNDERSIZED ON THE PRIMARY SURGERY, NO LOOSENING AND NO SURGICAL DELAY REPORTED.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 16452439 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR AN INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. DOI: (B)(6) 2021. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13044118 ↗
• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF KNEE. POLY SWAP WAS DONE AND NOTHING WAS BROKEN OR IMPACTED. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2021 UNKNOWN KNEE SIDE.

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

  MAUDE report 12283183 ↗
• MalfunctionMay 21, 2020Fracture; Fracture

  1. WAS THE EVENT HAPPEN DURING PRIMARY SURGERY OR REVISION SURGERY. PRIMARY. 2. IT IS STATED IN THE EVENT DESCRIPTION THAT "WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. IF YES, NUMBER OF MINUTES: 3 MIN," CAN YOU PLEASE CLARIFY WHAT YOU HAVE STATED FOR THE DURATION OF DELAY IS IT 3 DAYS OR 3 MINS? 3 MIN. 3. CAN YOU PLEASE PROVIDE THE REASON WHY THE POLY INSERT BROKE? DUE TO THE NATURE OF THE REPORTED EVENT, AND IN ACCORDANCE WITH OUR PROCEDURES, WE ARE REQUIRED TO REQUEST THE FOLLOWING INFORMATION TO ASSIST IN THE INVESTIGATION. PLEASE COULD YOU LET ME KNOW IF ANY/NONE OF THIS INFORMATION IS AVAILABLE: PATIENT DEMOGRAPHICS THE FOLLOWING ARE THE TYPES OF PATIENT DEMOGRAPHICS WE REQUIRE: RELEVANT COMORBIDITIES, DATE OF IMPLANTATION ,(B)(6)2020.

  Patient problems: No Code Available

  MAUDE report 10080380 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED RIGHT KNEE. REMOVAL DATE (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9871647 ↗
• MalfunctionJun 20, 2019Difficult to Insert; Difficult to Insert

  TODAY (B)(6) DOCTOR PERFORMED A LEFT KNEE REPLACEMENT. DOCTOR COULD NOT GET THE INSERT TO CLICK INTO THE TIBIAL TRAY ON THE LATERAL SIDE.

  Patient problems: Not Applicable

  MAUDE report 8716595 ↗
• MalfunctionMar 21, 2018Break; Break

  DER STATES IMPLANT BROKE AT THE LOCKING INTERFACE DURING IMPACTION INTO THE TIBIA TRAY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7359216 ↗
• InjuryFeb 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  INFECTED KNEE JOINT.

  Patient problems: Unspecified Infection

  MAUDE report 7298954 ↗
• MalfunctionJul 21, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE SURGERY THE INSERT WAS NOT CONNECTED INTO A TIBIAL TRAY.

  Patient problems: No Information

  MAUDE report 6732301 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033272, K241000. One submission often covers many models, so check the product and lot details in each record.

• Z-0421-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or defin
• Z-0417-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or de
• Z-0420-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive
• Z-0422-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definit
• Z-0414-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or defin
• Z-0416-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or d
• Z-0412-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or de
• Z-0423-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definit
• Z-0419-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive
• Z-0413-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or def
• Z-0418-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definiti
• Z-0415-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or
• Z-1184-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-24-008.
• Z-1178-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 10 mm; Ref 1581-22-010.
• Z-1189-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 22.5 mm; Ref 1581-24-022.

…and 36 more.