NA 86-7414Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 10603295217824), received between Jun 28, 2017 and Aug 7, 2026 — classified as 91 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (9 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 92 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 50173040 ↗
• InjuryMay 5, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT PRESENTED AT EMERGENCY ROOM (ER) WITH LOOSE TIBIAL COMPONENT. TIBIAL COMPONENT WAS REMOVED AND REVISED WITHOUT DELAY OR HARM NOTED. IT WAS STATED THAT TIBIAL SLEEVE AND STEM WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2013, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25086179 ↗
• InjuryDec 16, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO FEMORAL SLEEVE AND STEM APPEAR LOOSE ON XRAY. FEMORAL SIDE COMPONENTS ARE REMOVED AND NEW COMPONENTS ARE PLACED WITHOUT DELAY OR HARM. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23818499 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF THIGH PAIN. THERE WAS A LUCENCY AROUND THE STEM ON X-RAY. OPERATIVELY, THE SLEEVE WAS WELL FIXED BUT SURGEON WAS CONCERNED AND REMOVED ALL FEMORAL COMPONENTS. TIBIAL COMPONENT APPEARED TO BE WELL FIXED AND WAS LEFT IN PLACE. A DISTAL FEMORAL REPLACEMENT WAS PLACED WITHOUT DELAY OR PATIENT HARM. DOI: ON (B)(6) 2017, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT SIDE.

  Patient problems: Pain

  MAUDE report 23584895 ↗
• InjuryAug 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: SIGMA FEMORAL STEM, SLEEVE, AND COMPONENT AS WELL AS THE TIBIAL SLEEVE, TIBIAL STEM, AND TIBIAL TRAY WERE REVISED FOR LOOSENING AT UNKNOWN INTERFACE. THE TRUNNION OF THE TIBIAL STEM SHOWS MINOR FRETTING. THE TIBIAL SLEEVE SHOWS MINOR CORROSION.

  Patient problems: Insufficient Information

  MAUDE report 22769550 ↗
• InjuryJul 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT WAS DUE TO BONE LOSS. CONVERTED TO A DFR. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Notching

  MAUDE report 22484390 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY OPERATED ON FOR AN INFECTED NON-UNION OF FUSION. SINCE CULTURES WERE NEGATIVE, SURGEON CHOSE TO REIMPLANT THE PATIENT. CONTINUED DRAINAGE SUGGESTS INFECTION. SINCE THE PATIENT CONTINUES TO DRAIN DESPITE NEGATIVE CULTURES, THE SURGEON CHOSE TO REMOVE ALL COMPONENTS AND CONVERT TO A STATIC SPACER UTILIZING LPS COMPONENTS, PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND HIGH DOSE ANTIBIOTIC CEMENT TO COAT THE COMPONENTS. ALL COMPONENTS WERE WELL FIXED BUT LACK OF BONY INGROWTH ALSO SUGGESTS PERSISTENT INFECTION. AN I&D WAS PERFORMED ON (B)(6) 2025, WHERE THE POLY AND PIN WERE REPLACED. DEPUY 2 WITH GENTAMICIN WAS LIKELY UTILIZED, AS THAT IS THE SURGEON'S NORM. NO DELAY OCCURRED AND NO PATIENT HARM WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22214714 ↗
• InjuryApr 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POSSIBLE ASEPTIC LOOSENING. REMOVED ALL IMPLANTS AND CONVERTED TO ATTUNE REVISION KNEE IMPLANTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21892742 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THERE WAS REVISION OF TIBIAL CONSTRUCT AS THERE WAS NO IN-GROWTH BETWEEN THE SLEEVE AND BONE AND TIBIAL STEM WAS IMPINGING ON THE TIBIAL INTRAMEDULLARY CORTEX. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21575826 ↗
• InjuryOct 30, 2024Osseointegration Problem; Osseointegration Problem

  REVISION OF LCS COMPLETE REVISION COMPONENTS. IMPLANTS REVISED DUE TO SUSPECTED INFECTION AND LOOSENING. VERY MINIMAL BONE GROWTH ON THE STEM AND SLEEVE. IMPLANTS WERE REMOVED VERY EASILY. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: INFECTION AND LOOSENING, DID PATIENT REQUIRE REVISION SURGERY? TRUE, IF YES, DATE OF REVISION SURGERY. REASON FOR REVISION SURGERY. INFECTION AND LOOSENING, PATIENT STATUS/ OUTCOME / CONSEQUENCES YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PAIN DUE TO INFECTION AND LOOSENING, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, IP-(B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-(B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-(B)(4) DEVICE PROP

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 20567685 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CHRONIC INFECTION OF RIGHT KNEE. DOI: (B)(6) 2020 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20439997 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC PAIN. PATIENT SEEN IN ED WITH DISLOCATED KNEE. CORRECTIVE SURGERY HAD MASSIVE METALOSIS, OSTEOLYSIS, AND POLYETHYLENE WEAR. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL: YES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 20279444 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN TO DRAIN AGAIN POST ANTIBIOTIC SPACER FASHIONED WITH LPS COMPONENTS. ALL COMPONENTS WERE REMOVED. DURING DISSECTION AND REMOVAL, A VASCULAR INJURY OCCURRED. THE VASCULAR TEAM CAME IN TO REPAIR THE VESSELS. A NEW SPACER UTILIZING LPS COMPONENTS WAS PLACED AFTER A THOROUGH DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS A DELAY IN THE PROCEDURE AND HARM DID OCCUR BUT THERE WAS NO MENTION OF ALLEGATION AGAINST ANY DEPUY COMPONENTS CAUSING SAID INJURY. DOI: (B)(6), 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Perforation of Vessels

  MAUDE report 20239531 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SYMPTOMS OF INFECTION. ALL COMPONENTS WERE REMOVED, A THOROUGH I&D PERFORMED AND A ACER WAS FASHIONED OF LPS COMPONENTS. NO DELAY NOR PATIENT HARM WAS NOTED. ALL COMPONENTS WERE WELL FIXED AND INGROWN. PATIENT DID HAVE A COMPONENT EXCHANGE WITH I&D PERFORMED ON (B)(6) 2024 DUE TO A FALL. (B)(4) WAS FILED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19809584 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  J-C HEALTH CARE LTD. RECEIVED ON 9 APRIL 2024 A DEMAND LETTER DATED 28 MARCH 2024 PERTAINING TO A TOTAL KNEE REPLACEMENT WITH SIGMA IMPLANT. ACCORDING TO THE DEMAND LETTER, BACK IN 2019 PATIENT UNDERWENT A LT TKR IN RUSSIA (UNKNOWN IMPLANT) AND SUFFERED FROM INFECTION. THEREAFTER PATENT UNDERWENT SEVERAL INFECTION REVISIONS (ALSO IN RUSSIA) INCLUDING REMOVAL OF TIBIAL IMPLANT AND INSERTION OF SPACER, THAT DID NOT SOLVE THE INFECTION. DURING FEBRUARY-JULY 2020 PATIENT WAS TREATED AT (B)(6) IN ISRAEL. ON (B)(6) 2020 (B)(4) CAPTURED FOR THE 1ST REVISION) PATIENT UNDERWENT A FIRST STAGE OF LT TKR REVISION AT SHEBA MEDICAL CENTER DUE TO "INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL JOINT PROSTHESIS (LEFT)" DURING WHICH HER IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. THEREAFTER PATIENT WAS PLACED IN PLASTER CAST/BRACE AND KNEE FIXATION AND RECEIVED A LONG TERM SYSTEMIC ANTIBIOTIC TREATMENT UNDER LABORATORY MONITORING. AFTER 6 WEEKS OF ANTIBIOTIC TREATMENT WITH VANCOMYCIN AND LABORATORY MONITORING FOR ADDITIONAL 2 MONTHS, IT WAS FOUND THAT THERE WAS NO INFLAMMATION OF THE INFECTION FOLLOWING CESSATION OF THE ANTIBIOTICS AND THE KNEE WAS "QUIET", THE SECOND STAGE

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Loss of Range of Motion; Physical Asymmetry

  MAUDE report 19173463 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A FIRST STAGE REVISION FOR INFECTION. TC3 IMPLANTS INSITU WHICH WERE REMOVED AND A CEMENT SPACER REPLACED. REVISION WILL BE BOOKED ONCE INFECTION CLEARS. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18785470 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. NO DELAY. DOI- (B)(6) 2020. DOR- (B)(6) 2023. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18118862 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED AGAIN IN 2017 WITH PAIN & BONE SCANS SUGGESTING LOOSENING - REVISED ENTIRE CONSTRUCT TO TC3 WITH MBT SLEEVES & STEMS.

  Patient problems: Pain

  MAUDE report 17564581 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN S ROM FEMORAL STEM WITH A 52MM PINNACLE CUP, 52X36 METAL LINER AND A 36MM +0 METAL FEMORAL HEAD. THE PATIENT WAS REVISED DUE TO HIGH METAL ION LEVELS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 17479086 ↗
• InjuryAug 4, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD PRIMARY TKR AND HAS HAD ONGOING ISSUES SINCE WITH PAIN, SWELLING AND LOOSENING. PATIENT HAD A PARTIAL REVISION FOR PAIN AND LOOSENING. PATIENT PRESENTED AGAIN WITH PAIN AND BONE SCANS SUGGESTING LOOSENING. REVISED ENTIRE CONSTRUCT. PRESENTED AGAIN WITH PAIN. BONE SCAN SUGGESTED LOOSENING SO REVISED TO ATTUNE REVISION WITH STEMS AND SLEEVES. IMPLANTS WEREN'T GROSSLY LOOSE AND REQUIRED SOME WORK (FLEXIBLE OSTEOTOMES AROUND METAPHYSEAL SLEEVES AND SLAP HAMMER ATTACHMENTS) TO REMOVE. DOI: (B)(6) 2017. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 17459438 ↗
• InjuryJul 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE JOINT WAS INFECTED AND THE SLEEVE WAS TOTALLY LOOSE. STEM AND SLEEVE SCREW TOTALLY BROKEN. THE STEM WAS VERY WELL FIXED IN THE OLD CEMENT. DOI: (B)(6) 2022. DOE: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17350909 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RETURNED TO SURGERY FOR AN INFECTED LEFT HINGE KNEE. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED. THERE WERE NO SURGICAL DELAYS, DEFICIENCIES OR BROKEN INSTRUMENTS. DOI: (B)(6) 2019, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17134933 ↗
• InjuryJun 7, 2023Device Dislodged or Dislocated; No Apparent Adverse Event; Device Dislodged or Dislocated; No Apparent Adverse Event

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078553 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL FEMUR. PATIENT HAD REVISION COMPONENTS PREVIOUSLY. TOOK ALL OUT AND REDID FEMORAL REVISION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Pain

  MAUDE report 16896569 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16214054 ↗