SIGMA AOX 1961-92-042Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10603295076216), received between Nov 9, 2017 and Jan 27, 2026 — classified as 38 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE PAIN. POLY WAS REVISED FROM A 4X12.5 SIGMA RP CVD TO A 4X17.5. THE 17.5 WAS NOT AVAILABLE SO THE POST WAS SHAVED OFF OF A 4X17.5 RPPS. DOI: (B)(6) 2018, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24189835 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF KNEE. SURGEON DID WASHOUT I&D WITH POLY SWAP. KNEE WENT FROM SIGMA 4X12.5 TO 4X15 RP CVD. DOI: UNKNOWN DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22234795 ↗
• InjuryDec 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ORIGINAL PROCEDURE WAS RIGHT TOTAL KNEE AND WAS PERFORMED ON (B)(6) 2021. IN (B)(6) 2024 THE PATIENT REPORTED PAIN AND WAS GIVEN A CORTICOSTEROID INJECTION. IN (B)(6) 2024, THE PATENT CONTINUED TO EXPERIENCE PAIN. BONE SCAN SHOWED SIGNIFICANT UPTAKE AROUND THE TIBIAL COMPONENT. MODERATE KNEE SWELLING. X-RAYS ALSO SHOWED THE TIBIAL COMPONENT HAD COLLAPSED INTO VALGUS. REVISION WAS RECOMMENDED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. THE TIBIA WAS LOOSE, THERE WAS LITTLE POLY WEAR, AND CEMENT USED WAS UNKNOWN. IT WAS UNKNOWN AS TO WHY THE COMPONENT WAS LOOSE. THERE WAS NO SIGNS OF INFECTION. TWO IMPLANTS WERE REMOVED ON (B)(6) 2024. NO COMPLICATION OR EXTENDED TIME IN OPERATION. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 20835473 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4) STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2023, DATE OF EVENT: ON (B)(6) 2024, (LEFT KNEE). TREATMENT: ASPIRATION/DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 19252387 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES RECEIVED. ON (B)(6) 2023, THE PATIENT HAD A LEFT HYBRID TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS, END-STAGE, LEFT KNEE. DEPUY COMPONENTS WERE IMPLANTED, INCLUDING DEPUY PATELLA, AND DEPUY CEMENT.

  Patient problems: Pain

  MAUDE report 18959993 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM MEDICAL RECORDS NOTE: THE PATIENT IS FOLLOW-UP STATUS POST I&D, WASHOUT, LEFT KNEE. PATIENT HAS BEEN DOING WELL AND WILL CONTINUE TO USE THEIR IMMOBILIZER.

  Patient problems: Unspecified Infection

  MAUDE report 18290912 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENTS KNEE WAS UNSTABLE SO THE SURGEON SWAPPED THE INSERT. WHILE HE WAS IN THE JOINT, HE ALSO CHANGED THE PATELLA OUT.

  Patient problems: Joint Laxity

  MAUDE report 18038403 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SAME SURGERY ON (B)(6) 2023, THE SURGEON ADDRESSED COMPLAINTS OF RIGHT PATELLAR CLUNK BY PERFORMING A SCOPE OF THE RIGHT KNEE. HE IDENTIFIED HYPERTROPHIC SCAR ON THE UNDERSURFACE OF THE QUADRICEPS TENDON, WHICH WAS REMOVED. SCAR WAS ALSO REMOVED AROUND THE PERIPHERY OF THE PATELLA, WHICH ALLOWED THE PATELLA TO TRACK NICELY. NO IMPLANTS WERE REVISED ON THE RIGHT SIDE. DOI: (B)(6) 2016. (B)(6) 2022 (INSERT). DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Unspecified Tissue Injury

  MAUDE report 17265607 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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) 2016. DATE OF REVISION: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE) TREATMENT: REVISION AND I&D; INSERT WAS REVISED.

  Patient problems: Fever; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16095300 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS. 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; (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

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

  MAUDE report 15966128 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2009. DATE OF REVISION: (B)(6) 2016. DATE OF REVISION: (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION; INSERT REMOVED.

  Patient problems: Fluid Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15122743 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CALF PAIN, VASCULAR DEEP VEIN THROMBOSIS - LEFT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022; DATE OF EVENT: (B)(6) 2022 TREATMENT: ORAL MEDICATION ELIQUIS.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 14488195 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CALF PAIN, VASCULAR DEEP VEIN THROMBOSIS - LEFT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022 ;DATE OF EVENT: (B)(6) 2022. TREATMENT: ORAL MEDICATION ELIQUIS.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 14487977 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. INSERT EXCHANGE. DATE OF IMPLANT: (B)(6) 2016. DATE OF REVISION: (B)(6) 2022. (RIGHT KNEE).

  Patient problems: Abscess; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 14239597 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR JOINT LAXITY AND INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2016, DATE OF REVISION: (B)(6) 2022, (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14084527 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LATERAL ABSCESS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2009, DATE OF IMPLANT INSERT: (B)(6) 2016, DATE OF EVENT: (B)(6) 2022, (RIGHT KNEE). TREATMENT: IRRIGATION AND DEBRIDEMENT.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 14083838 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY: DOTS . CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE TO ADDRESS INSTABILITY DATE OF IMPLANTATION: (B)(6) 2020; DATE OF REVISION: (B)(6) 2021; (LEFT KNEE). TREATMENT: REVISION OF INSERT COMPONENT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13152808 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED MID FLEXION INSTABILITY FOLLOWING A SIGMA RP CR CONSTRUCT. THE INSERT WAS REPLACED WITH A THICKER INSERT TO TENSION THE KNEE APPROPRIATELY. DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (LEFT KNEE).

  Patient problems: Joint Laxity

  MAUDE report 13047673 ↗
• InjuryNov 1, 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 GLOBAL INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2020, DATE OF EVENT: (B)(6) 2021, DATE OF REVISION: DATE NOT PROVIDED. TREATMENT: REVISION OF THE TIBIAL INSERT.

  Patient problems: Joint Laxity

  MAUDE report 12727820 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DOTS. (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION AS WELL AS BONE RESORPTIVE CHANGES. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: PT HAD A WASHOUT OF HIS NATIVE ANKLE FOR SEPSIS, NO FURTHER TREATMENT WITH ANTIBIIOTICS.

  Patient problems: Adhesion(s); Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12673713 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE INSTABILITY EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY, WITH POSSIBLE CONSIDERATION FOR REVISION IN THE FUTURE.

  Patient problems: Joint Laxity

  MAUDE report 11679879 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT BILATERAL PRIMARY KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY PRODUCTS AND CEMENT WERE UTILIZED IN BOTH KNEES. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT PRESENTED FOR A BILATERAL KNEE EVALUATION. IN THE RIGHT KNEE, THE PATIENT WAS EXPERIENCING PAIN, DISCOMFORT, SWELLING, AND A PALPABLE POP WHEN GOING FROM FLEXION TO EXTENSION. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE ARTHROTOMY WITH OSTECTOMY OF HETEROTOPIC BONE OF DORSAL FEMUR. THE SURGEON NOTED A SIGNIFICANT AMOUNT OF CREPITUS UNDER THE EXTENSOR MECHANISM OF THE RIGHT KNEE. THE SURGEON ALSO NOTED EXCISING MODERATE HYPERTROPHIC SYNOVITIS. NO PRODUCTS WERE REVISED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT PRESENTED FOR A POST-OPERATIVE EVALUATION OF THE RIGHT KNEE. THE PATIENT WAS NOTED TO BE DOING VERY WELL WITH NO ISSUES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Calcium Deposits/Calcification; Discomfort; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11516701 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY:(B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS FEMORAL OSTEOLYSIS. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: FEMUR AND TIBIAL INSERT REVISED. ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2019, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. DEPUY PRODUCTS WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS PAIN, DISCOMFORT, EDEMA, INSTABILITY, WALKING DIFFICULTY, AND OSTEOLYSIS. PRE-OPERATIVELY THE SURGEON SUSPECTED FEMORAL COMPONENT WAS LOOSE, HOWEVER, THE REVISION OPERATIVE NOTE CONFIRMED THE FEMORAL COMPONENT WAS WELL-FIXED. THE SURGEON NOTED MINIMAL BONE LOSS TO THE FEMUR. THE TIBIAL INSERT AND FEMORAL COMPONENT WERE REVISED. THE TIBIAL TRAY AND PATELLAR COMPONENT WERE RETAINED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

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

  MAUDE report 11371972 ↗
• InjuryJan 6, 2021Unintended Movement; Unintended Movement

  THE PATIENT WAS REVISED TO ADDRESS A SPIN-OUT OF THE POLY. A REPLACEMENT WITH A THICKER POLY WAS DONE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11123409 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED DVT WITH ONSET ON (B)(6) 2020, AND WAS TREATED WITH LOVENOX AND COUMADIN, AND THEN ELIQUIS. AT THE TIME OF THE CLINICAL VISIT, THE PATIENT PRESENTED WITH SOME RESIDUAL KNEE SWELLING, BUT WAS OTHERWISE NON-SYMPTOMATIC.

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 11087156 ↗