SIGMA AOX 1961-92-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295076254), received between Feb 16, 2018 and Nov 21, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. WASHOUT I&D WAS PREFORMED. POLY WAS SWAPPED FROM 5X12.5 TO 5X15 SIGMA RP CVD. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23619228 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED KNEE. IMPLANTS WERE REMOVED. CEMENT SPACER WAS PUT IN. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21988172 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS FEELING UNSTABLE, FEMORAL COMPONENT WAS LOOSE. SURGEON REMOVED AND REPLACED WITH SIGMA REVISION IMPLANTS. NO LOSS OF TIME. DOI: (B)(6) 2013. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21883159 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: A. WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO. B. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? REVISION SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 20544175 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT UNDERWENT A SIGMA RP CVD CONSTRUCT IN 2022. UNFORTUNATELY, THE PATIENT IS CONFIRMED, FOR INFECTION. A POLY SWAP AND WASHOUT WAS PERFORMED. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20236306 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? -NO. B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -NO.

  Patient problems: Unspecified Infection

  MAUDE report 18980130 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS ACUTE SEPSIS. THE PATIENT HAD A FALL, THE WOUND DEHISCED A LITTLE BIT SUPERFICIALLY, THEN DEVELOPED A DEEP INFECTION. THE PATIENT HAD AN IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Sepsis; Unspecified Infection; Wound Dehiscence

  MAUDE report 17765444 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST OP MI. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022; DATE OF EVENT: (B)(6) 2022; (RIGHT AND LEFT KNEE). TREATMENT: ORAL MEDICATION (PLAVIX).

  Patient problems: Chest Pain; Myocardial Infarction

  MAUDE report 16183171 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN. ABNORMAL XRAY: EVIDENCE OF ASEPTIC LOOSENING AND MIGRATION OF THE TIBIAL COMPONENT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2020, DATE OF EVENT: (B)(6) 2022, DATE OF REVISION: NOT PROVIDED, (LEFT KNEE). TREATMENT: REVISION OF THE TIBIAL AND INSERT COMPONENTS.

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

  MAUDE report 14115336 ↗
• InjuryApr 1, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY AND HEMARTHROSIS. DATE OF IMPLANT: (B)(6) 2016. DATE OF REVISION: (B)(6) /2022 . (LEFT KNEE). TREATMENT: REVISION OF THE TIBIAL INSERT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Swelling/ Edema; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 13978301 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR QUAD TENDON TEAR VS DISRUPTION OF MEDIAL ARTHROTOMY : PAIN, SEVERE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2022, (LEFT KNEE). TREATMENT: CERCLAGE REPAIR OF PATELLAR TENDON AND DISRUPTED CAPSULAR ARTHROTOMY.

  Patient problems: Loss of Range of Motion; Muscle/Tendon Damage; Pain; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 13440021 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(4). 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 (B)(6) 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 ALT

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

  MAUDE report 11871039 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LEFT LOWER EXTREMITY DVT : VASCULAR - DVT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: INJECTED MEDICATION LOVENOX; ORAL MEDICATION: COUMADIN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11120424 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FOR MEDICAL RECORDS. PATIENT RECEIVED BILATERAL DEPUY HYBRID TKAS TO TREAT CHRONIC PAIN SECONDARY TO END-STAGE ARTHROSIS. THIS COMPLAINT WILL CAPTURE THE LEFT KNEE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE SURGEON NOTES THE LEFT KNEE HAD 1-MM LAXITY IN VARUS/VALGUS STRESSES IN FLEXION AND EXTENSION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A SURGICAL I & D AND WOUND REPAIR TO TREAT PAIN AND WOUND DEHISCENCE SECONDARY TO A FALL. THERE WAS NO REPORTED PRODUCT PROBLEM WITH ANY IMPLANT AND THERE WERE NO REVISIONS PERFORMED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. OF NOTE: THE PATIENT SUSTAINED AN IMPACTED TROCHANTERIC FRACTURE DURING THE FALL. IN CONSULTATION WITH AN SME, IT WAS DETERMINED TO NOTE THE TROCHANTERIC FRACTURE AS A NOTE ON THIS COMPLAINT. THERE WAS NO INFORMATION REGARDING TREATMENT OF THE FRACTURE. THEREFORE, IT WILL NOT BE CAPTURED WITHIN THIS COMPLAINT. DOI: (B)(6) 2020, DOE: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain; Wound Dehiscence

  MAUDE report 10262396 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INFECTION DATE OF IMPLANTATION: (B)(6) 2019; DATE OF REVISION: (B)(6) 2020; (LEFT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Adhesion(s); Edema; Fever; No Code Available; Pain; Tachycardia; Unspecified Infection

  MAUDE report 9808271 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, SWELLING, INFECTION, FEVER, AND EFFUSION. PRIOR TO REVISION, THE PATIENT HAD PERIODS OF TACHYCARDIA. THE SURGEON NOTED REMOVAL OF FIBRINOUS TISSUE. THE TIBIAL INSERT WAS THE ONLY PRODUCT REVISED. ALL COMPONENTS WERE WELL FIXED. THE SURGEON ALSO PERFORMED AN IRRIGATION AND DEBRIDEMENT AND PLACEMENT OF ANTIBIOTIC PELLETS.

  Patient problems: Adhesion(s); Edema; Fever; No Code Available; Pain; Unspecified Infection

  MAUDE report 9770968 ↗
• InjuryFeb 24, 2020Unintended Movement; Unintended Movement

  CLINICAL ADVERSE EVENT RECEIVED FOR ROTATING PLATFORM, SPINOUT OF SPACER. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: RIGHT KNEE REVISION ON (B)(6) 2020, (FEMUR AND TIBIAL INSERT REVISED).

  Patient problems: Damage to Ligament(s); Joint Disorder; No Code Available; Pain

  MAUDE report 9746548 ↗
• InjuryJan 14, 2020Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS INFECTION, POLY WEAR AND TEAR. THE SURGEON DECIDED TO WASH THE KNEE OUT. THE POLY WAS SWAPPED AND UPSIZED FOR STABILITY. NO MORE PATIENT INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9586808 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR HEMARTHROSIS AND SUSPECTED LOOSENING, THERE IS LYTIC AREA IN FEMUR ZONE 1, QUESTION OF INFECTION AS WELL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT: (B)(6) 2019. (LEFT KNEE). TREATMENT: LEFT KNEE REVISED TO ADDRESS INFECTION, WITH REMOVAL OF ALL IMPLANTS, AND PLACEMENT OF AN ANTIBIOTIC SPACER. DEPUY COMPONENTS: CATALOG ID: 960103, LOT: 8966832, DESCRIPTION: SIGMA PATELLA OVAL DOME 3 PEGGED 41MM; CATALOG ID: 129433150, LOT: 8979680, DESCRIPTION: MBT CEMENTED KEEL SZ 5; CATALOG ID: 196192052, LOT: 8956325, DESCRIPTION: AOX CVD RP TIBIAL INSERT SZ 5 12.5MM ; CATALOG ID: 960005, LOT: 9030602, DESCRIPTION: SIGMA FEM C/RET CEMENTED LT SZ 5; CATALOG ID: 3332040, LOT: 8835332, DESCRIPTION: SMART SET BONE CEMENT CMW3 ; CATALOG ID: 3332040, LOT: 8835332, DESCRIPTION: SMART SET BONE CEMENT CMW3;

  Patient problems: Fall; No Code Available; Osteolysis; Pain; Swelling; Unspecified Infection

  MAUDE report 9202743 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS ((B)(4) MEDICAL RECORDS AD 17 OCT 2019) REVIEWED. CT SCAN OF THE LEFT KNEE WITH 3D RECONSTRUCTION OCCURRED ON (B)(6) 2019. THERE WAS NO EVIDENCE OF BONE FRACTURE. THERE WAS EVIDENCE OF POSSIBLE LINEAR LUCENCY AT THE UNDERSURFACE OF THE MEDIAL TIBIAL TRAY, BETWEEN THE TIBIAL IMPLANT AND THE CEMENT. THERE IS ADDITIONAL LUCENCY BETWEEN THE BONE AND CEMENT MANTLE, APPEARANCE CONSISTENT WITH OSTEOLYSIS. LESS CLEAR WAS EVIDENCE AT THE FAR LATERAL BOUNDARY OF THE TRAY FOR OSTEOLYSIS. THERE WAS NO EVIDENCE OF LUCENCY OR OSTEOLYSIS ASSOCIATED WITH THE FEMUR OR PATELLAR COMPONENTS. THERE WAS EVIDENCE OF A LARGE KNEE JOINT EFFUSION DISTENDING THE SUPRAPATELLAR BURSA, WITH SOFT TISSUE EDEMA IN THE PROXIMAL KNEE. CULTURES: DIRECT GRAM STAIN RECEIVED ON (B)(6) 2019 REVEALED MODERATE POLYMORPHONUCLEAR LEUKOCYTES, HEAVY RED BLOOD CELLS, AND NO ORGANISMS OBSERVED. GRAM POSITIVE COCCI IN CLUSTERS SEEN IN BROTH MEDIA GRAM STAIN ONLY. WBCS 11.1 ELEVATED. RED CELL DISTRIBUTION WIDTH CV 17.6 ELEVATED. NEUTROPHILS ABSOLUTE 7.9 ELEVATED. MONOCYTES ABSOLUTE 1.3 ELEVATED. D-DIMER 1450 NG/ML ELEVATED. ON (B)(6) 2019 SYNOVASURE ALPHA DEFENSIN PJI LDT - POSITIVE : ABNORMAL. ALPHA DEFENSIN S-SF:

  Patient problems: Edema; No Code Available; Osteolysis; Unspecified Infection

  MAUDE report 9197518 ↗
• InjuryFeb 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION - DEEP. HEMATOGENOUS SEEDING. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. TREATMENT INCLUDES REVISION OF THE INSERT. DOI: (B)(6) 2014; DOE: (B)(6) 2017; DOR: (B)(6) 2017; (RIGHT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 7276377 ↗