P.F.C. SIGMA 96-0100Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10603295232605), received between Jun 26, 2017 and Aug 20, 2025 — classified as 58 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 62 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT VOLUNTARY REPORT WAS RECEIVED ((B)(4)) ORIGINAL SURGERY DATE FOR RIGHT TOTAL KNEE ARTHROPLASTY (B)(6) 2021 PATIENT REQUIRED A KNEE REPLACEMENT (B)(6) 2025. WHEN THE OLD KNEE REPLACEMENT WAS REMOVED, THERE WAS SIGNIFICANT DAMAGE TO THE JOINT WHICH WAS NOT EXPECTED AND SEEMED TO BE A MANUFACTURING DEFECT. DOI: (B)(6) 2021. DOR:(B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 22849579 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED: ON (B)(6) 2024, MEDICAL RECORDS NOTED THE PATIENT IS 6 WEEKS POST HIP ARTHROPLASTY. IT WAS SAID THAT THE PATIENT HAD A CT SCAN TWO WEEKS AGO AND IT SHOWED A PULMONARY EMBOLISM. THE PATIENT WAS PRESCRIBED ELIQUIS MEDICATION AND OVERALL IS DOING WELL. ON (B)(6) 2024, THE PATIENT IS NOW 3 ½ MONTHS OUT FROM A RIGHT TOTAL HIP IT WAS NOTED THAT THE PATIENT HAD A PE AFTERWARDS. DEPUY STEM AND CUP ARE REPORTED TO BE WELL PLACED ON A RADIOGRAPH.

  Patient problems: Pulmonary Embolism

  MAUDE report 20280892 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 12 MAR 2024 WAS REVIEWED BY CLINICIAN. ON (B)(6) 2014, THE PATIENT HAD A BILATERAL CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS, BILATERAL KNEE PAIN AND BILATERAL KNEE OSTEOARTHRITIS END-STAGE. ALL COMPONENTS IMPLANTED WERE DEPUY PRODUCTS, INCLUDING THE CEMENT AND PATELLA. ON (B)(6) 2020, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY, TO ADDRESS MECHANICAL LOOSENING OF INTERNAL RIGHT KNEE PROSTHETIC JOINT. THE SURGEON REPORTED FINDING TIBIAL TRAY LOOSENING. THE FEMORAL COMPONENT WAS WELL FIXED, BUT THERE WAS SIGNIFICANT OSTEOLYSIS BEHIND THE FEMORAL IMPLANT WITH LARGE CAVITARY DEFECT. SIGNIFICANT SYNOVITIS WAS ALSO NOTED. COMPETITOR PRODUCTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2014 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 18993264 ↗
• MalfunctionMar 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PATELLAR CLUNK. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2012 , DATE OF REVISION: 19 SEP 2023, DATE OF EVENT: 28 FEB 2024, (RIGHT KNEE) TREATMENT: NONE.

  Patient problems: Insufficient Information

  MAUDE report 18862829 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INFECTION. THERE WAS A LOOSENING REPORTED AT THE TIBIA AT CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18425992 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPECTED PERIPROSTHETIC INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 18248084 ↗
• InjuryNov 7, 2023Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO PATELLA WEAR AND POLY EXCHANGE. SURGEON WASN¿T SURE WHEN THE PREVIOUS SURGERY WAS DONE OR WHERE IT WAS DONE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 18085778 ↗
• InjuryNov 3, 2023Naturally Worn; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. DATE OF IMPLANT: (B)(6) 2012. DATE OF REVISION: (B)(6) 2023. (RIGHT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REVISED. (B)(4), OPERATIVE NOTE AD (B)(6) 2023 AND (B)(4), CLINICAL NOTE AD (B)(6) 2023, WERE REVIEWED BY A CLINICIAN. ON (B)(6) 2023, THE PATIENT UNDERGOES A R KNEE REVISION SECONDARY TO PAIN, SWELLING AND INSTABILITY AFTER A FALL. XRAYS INDICATE LOOSENING WITH VALGUS COLLAPSE OF THE FEMORAL COMPONENT. INTRA-OPERATIVELY, THE FEMORAL SUBSIDENCE AND LOOSENING WERE CONFIRMED, THOUGH LOOSENING INTERFACE WAS NOT PROVIDED. MILD WEAR WAS NOTED ON THE PATELLAR COMPONENT, THOUGH IT WAS NOT REVISED.

  Patient problems: Discomfort; Fall; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 18065768 ↗
• 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 17116854 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT OF MINE HAD A LEFT KNEE REPLACEMENT ( OP NOTE ENCLOSED ). A 2.5 SIZED CRUCIATE SACRIFICING TKR WAS PERFORMED. HER POST OP RANGE ON THE TABLE WAS 3 - 120 DEGREES. ( ON THE RIGHT SIDE A SIZE 3 WAS INSERTED ). A FEW MONTHS LATER THE RANGE OF MOVEMENT IN THE LEFT KNEE REDUCED AND IN (B)(6) 2021 WAS 30 - 75 DEGREES. THE KNEE WAS REVISED AT ANOTHER HOSPITAL. PATIENT HAS COMPLAINED TO ME: THAT I HAVE USED TOO BIG A PROSTHESIS. THE IMPLANT IS TOO DISTAL.

  Patient problems: Loss of Range of Motion

  MAUDE report 16992294 ↗
• MalfunctionDec 28, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  FOREIGN PARTICLE - PAPER PIECE FOUND INSIDE THE INNER PRODUCT. THIS ISSUE WAS IDENTIFIED DURING LABELLING ACTIVITY. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061216 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH PAIN AND SWELLING SECONDARY TO A FALL ON (B)(6) 2022.

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

  MAUDE report 15289480 ↗
• MalfunctionAug 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATELLA LUXATION AFTER LPS SURGERY, CONTINUUM CARE PROCESS NEEDED. DOI: (B)(6). DOE: (B)(6). DOR: PENDING CUSTOM IMPLANT.

  Patient problems: Joint Dislocation

  MAUDE report 15211433 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTED KNEE. THE SURGEON DID AN EXPLANT AND I&D WITH ANTIBIOTIC SPACER. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14014508 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN I& D WITH A REVISION OF THE LEFT KNEE LPS HINGED INSERT TO TREAT PAIN AND SWELLING SECONDARY TO MRSA INFECTION. THE PATIENT WAS PLACED ON IV ANTIBIOTICS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR:(B)(6) 2016 . (LEFT KNEE).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 13567744 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AMPUTATION WAS DONE. DOI - (B)(6) 2015; DOR - (B)(6) 2016; UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 13549331 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DECREASED RANGE OF MOTION : ADHESIONS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016; DATE OF EVENT (ONSET): (B)(6) 2016; (LEFT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 13290580 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DECREASED RANGE OF MOTION : ADHESIONS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016; DATE OF EVENT (ONSET): (B)(6) 2016 (RIGHT KNEE). TREATMENT: RIGHT KNEE MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 13288944 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE, DECREASED RANGE OF MOTION : ADHESIONS EVENT IS NOT SERIOUS AND IS CONSIDERED MILD EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015. DATE OF EVENT (ONSET): (B)(6) 2016 (LEFT KNEE). TREATMENT: LEFT KNEE MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 13288710 ↗
• MalfunctionDec 30, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE COSTUMER OPENED A BOX DEFINED AS A PATELLA 32 MM, BUT INSIDE THE BOX THERE WAS A SIGMA RP-CR INSERT 4 - 17,5 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118499 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED THAT RESECTION WAS PERFORMED FOR INFECTION. DOI: (B)(6) 2017, DOR: UNKNOWN; RIGHT KNEE.

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

  MAUDE report 12437960 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT HAD AN EXCISION OF NODULAR FAT JUST ABOVE THE PREPATELLAR BURSA WITH REMOVAL OF MULTIPLE ETHIBOND SUTURES, RIGHT KNEE. THE BURSA HAD BECOME PAINFUL. THE SURGEON REPORTED FINDING NODULAR FATTY TISSUE JUST ABOVE THE PREPATELLAR BURSA, WHICH WAS CREATING SOMEWHAT OF A BAND ACROSS THE BURSA. THAT WAS THE MAIN ISSUE. THE SURGEON ALSO REMOVED MULTIPLE ETHIBOND SUTURES. DOI: (B)(6) 2016; DOE: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Inflammation; Pain

  MAUDE report 12211411 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF SEVERE PATELLA CREPITUS. THE XRAYS SHOW PATELLA BAJA. THE TIBIAL AND FEMORAL IMPLANTS WERE REMOVED AND EXCHANGED TO DISTALIZE THE JOINT LINE. THE SURGEON USES DEPUY 2 WITH GENT ROUTINELY ON REVISION KNEES BUT NO RECORDS ARE AVAILABLE AS IT IS HOSPITAL INVENTORY. DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12057812 ↗
• InjuryMay 17, 2021Use of Device Problem; Use of Device Problem

  THE PATIENT WAS REVISED DUE TO LACK OF MOTION AND PATELLA TRACKING. NO LOOSENING REPORTED. NO DELAYS DURING SURGERY. DOI: (B)(6), 2018. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 11832703 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY, AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. A TOTAL KNEE REVISION WAS PERFORMED. DOI: (B)(6) 2019. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11827286 ↗