SIGMA 94-0025Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295223498), received between Jul 5, 2018 and Nov 25, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

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

  CLINICAL NOTE AD (B)(6) 2024 REVIEWED BY A CLINICIAN. THE PATIENT PRESENTS AT A FOLLOW-UP APPOINTMENT. HE PREVIOUSLY HAD BILATERAL TOTAL KNEE REPLACEMENTS 17 YEARS AGO. 2 WEEKS PRIOR, THE PATIENT WAS RISING FROM A SEATED POSITION AND FELT A TWINGE IN HIS RIGHT KNEE WITH SOME MEDIAL BASED PAIN AND SWELLING. THE PATIENT HAS DIFFICULTY WALKING. A KNEE ASPIRATION WAS COMPLETED AND SENT FOR CULTURE AND HE WAS GIVEN A PROPHYLACTIC DOSE OF ANTIBIOTICS. HOWEVER, IT IS STATED "THIS IS MOST LIKELY A PINCH OF HIS SYNOVIUM." THE SYNOVIAL FLUID DID HAVE SOME BLOOD THAT WILL GO AWAY ON ITS OWN.

  Patient problems: Ambulation or Postural Difficulties; Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20773622 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TOTAL KNEE REPLACEMENT SURGERY ON THEIR RIGHT KNEE ON (B)(6) 2011. PATIENT UNDERWENT A TWO-STAGE REVISION FOR INFECTION ON (B)(6) 2013. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2011. DOR: (B)(6) 2013. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16059914 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  1.IT WAS INDICATED IN THE EVENT DESCRIPTION THAT ALL COMPONENTS APPEARED WELL FIXED BUT IT ALSO STATED THAT, "THERE WAS LITTLE IF ANY BONEY INGROWTH INTO THE POROUS COATING" WHEN THE FEMUR WAS REMOVED. PLEASE CLARIFY IF THERE WAS LOOSENING INVOLVED IN THIS EVENT. ANSWER: THE FEMORAL COMPONENT APPEARED WELL FIXED AND WAS NOT OVERTLY LOOSE ¿ NO MOVEMENT WAS DETECTED ¿ WHEN THE SURGEON WORKED AROUND THE FEMUR TO FREE THE FEMORAL COMPONENT ¿ THE FEMUR FINALLY WAS REMOVED AND THE UNDERSIDE OF THE FEMUR EXAMINED ¿ THE POROCOAT DID NOT SHOW ANY SIGNS OF BONEY INGROWTH, BUT RATHER A FIBROUS TISSUE INGROWTH ¿ SO I CAN ASSUME THEN THAT THE FEMUR MY HAVE BEEN LOOSE FROM THE TIME OF THE ORIGINAL INDEX REVISION AND THAT THE FIBROUS TISSUE INGROWTH WAS THE RESULT! 2. IT WAS REPORTED THAT THE KNEE HAS BEEN SCOPED IN THE PAST AND THAT SAMPLES WERE TAKEN. PLEASE VERIFY IF ANY OF THE PRODUCTS WERE REVISED/EXPLANTED DURING THIS EVENT. ANSWER: NO, NO IMPLANTS WERE REVISED AND AT THIS STAGE, AND I WAS NOT MADE AWARE OF THE SCOPE PROCEDURE. 3. WAS THE CEMENT PRODUCT MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PART AND LOT NUMBERS OF THE CEMENT. ANSWER: NO, THE CEMENT WAS NOT A DEPUY PROD

  Patient problems: Adhesion(s); Inadequate Osseointegration; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 11995832 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE RUPTURE OF PATELLAR TENDON. EVENT NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY IT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: AWAITING SURGICAL INTERVENTION. MEDICAL RECORDS RECEIVED WERE REVIEWED TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. ON (B)(6) 2021, THE PATIENT UNDERWENT A PRIMARY RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS WITH SEVERE VARUS DEFORMITY. DEPUY PFC SIGMA ROTATING PLATFORM KNEE WAS IMPLANTED WITH DEPUY CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON 3 MAY 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS PAIN, SWELLING, EFFUSION, DIFFICULTY WALKING, BRUISING, INSTABILITY, WITH BLEEDING AND ECCHYMOSIS DEVELOPING. IT WAS INDICATED TWO DAYS PRIOR, THE PATIENT WAS GOING DOWN A LADDER AND MISSED THE RUNG WITH HIS LEFT FOOT, CAUSING A HYPERFLEXION EPISODE TO THE RIGHT KNEE AND RESULTING IN AN ACUTE PATELLAR TENDON DISRUPTION. THE SURGEON NOTED THE ABSENCE OF THE PATELLAR TENDON AND HIS KNEECAP WAS IN THE PATELLAR ALTA

  Patient problems: Ambulation or Postural Difficulties; Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Muscle/Tendon Damage; Pain; Swelling/ Edema

  MAUDE report 11871035 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ILEUS, GASTROINTESTINAL : HOSPITALIZED 4-5-WEEKS COLECTOMY AND ILEOSTOMY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2019; (RIGHT KNEE).

  Patient problems: No Code Available

  MAUDE report 9623707 ↗
• InjuryJun 3, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS TIBIAL SUBSIDENCE AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. FULL DEPUY SIGMA REVISION WAS RE-IMPLANTED. NO PARTS WERE BROKEN DURING THE SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8662354 ↗
• InjuryJul 5, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 7663791 ↗