NA 1294-53-236Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10603295026334), received between Jun 23, 2017 and Apr 23, 2026 — classified as 56 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (7 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 56 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH PAIN IN FLEXION. IT WAS FOUND THAT THE HINGE COMPONENT WAS LOOSE. IT WAS REVISED TO A DFR. DOI- (B)(6) 2023. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24966281 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANT STIFFNESS WITH ESSENTIALLY NO MOTION POST REVISION TKA FOR STIFFNESS. SURGEON IS NOT SURE WHY PATIENT IS SO STIFF AS NO INFECTION IS PRESENT BASED ON LABS AND FROZEN SECTION. ALL COMPONENTS WERE REMOVED. FEMORAL SLEEVE WAS NOT INGROWN ALMOST 5 MONTHS POST OP. THERE WAS NO RADIOGRAPHIC INDICATION THAT COMPONENT WOULD BE LOOSE. TIBIAL COMPONENTS WERE SUBSEQUENTLY REMOVED TO LOWER THE JOINT LINE AS THE PATELLA WAS IMPINGING THE INSERT AFTER REVISING THE FEMUR. THIS IS LIKELY A RESULT OF SHORTENING OF THE PATELLAR TENDON DUE TO LACK OF MOTION. TIBIAL SLEEVE WAS ONLY PARTIALLY INGROWN. NO DELAY NOR PATIENT HARM WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 23709364 ↗
• InjuryDec 1, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT SURGEON REVISED PATIENT'S TC3 FEMORAL COMPONENT BECAUSE THE ATTACHED FEMORAL SLEEVE WAS LOOSE. DOI: (B)(6) 2017, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23687654 ↗
• 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- (B)(6) 2017. DOR- (B)(6) 2025. AFFECTED SIDE-LEFT SIDE.

  Patient problems: Pain

  MAUDE report 23584893 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: THE SIGMA FEMORAL COMPONENT, FEMORAL SLEEVE, FEMORAL STEM, INSERT, TIBIAL TRAY, TIBIAL SLEEVE, AND TIBIAL STEM WERE REVISED FOR INFECTION. THE INSERT SHOWED MODERATE YELLOWING.

  Patient problems: Unspecified Infection

  MAUDE report 22686049 ↗
• InjuryJun 6, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO SHOW SIGNS OF INFECTION AND WAS BROUGHT TO THE OR FOR BILATERAL KNEE REVISIONS. COMPONENTS WERE REMOVED AND THOROUGH I&DS WERE PERFORMED IN CONJUNCTION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS, AND PLACEMENT OF NEW COMPONENTS. PATIENT DID HAVE BILATERAL I&DS WITH POLY EXCHANGES ON (B)(6) 2025. AS SUCH, THE INSERTS LISTED ON THIS SUBMISSION WERE FROM THAT DATE. THE RIGHT KNEE SHOWED SIGNIFICANT HETEROTOPIC OSSIFICATION AROUND THE FEMORAL SLEEVE, SUGGESTING INFECTION ON XRAY, SO SURGEON TO CHOSE TO FASHION A STATIC SPACER UTILIZING LPS COMPONENTS TO TREAT THIS SIDE. THE LEFT SIDE APPEARED TO BE DOING BETTER, BUT SINCE HOSPITAL ADMISSION EARLIER THIS WEEK ALSO BEGIN TO SWELL. WHEN CHECKING FIXATION OF THE FEMORAL COMPONENT, THE FEMORAL SLEEVE WAS ABLE TO BE REMOVED WITHOUT SIGNS OF BONY INGROWTH. LACK OF INGROWTH APPROXIMATELY SEVEN (7) WEEKS POST IMPLANTATION SUGGESTS THIS TOO WAS INFECTED. TIBIAL COMPONENT AND STEM WERE LEFT IN PLACE ON THE LEFT SIDE SINCE IT WAS WELL FIXED. NO DELAY NOR PATIENT HARM WAS NOTED. WHILE RESULTS ARE NOT YET AVAILABLE, SURGEON DOES BELIEVE INFECTION WAS STILL PRESENT AT THE TIME OF THIS PROCEDURE. THIS INFEC

  Patient problems: Inadequate Osseointegration; Swelling/ Edema; Unspecified Infection

  MAUDE report 22160315 ↗
• InjuryJun 6, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO SHOW SIGNS OF INFECTION AND WAS BROUGHT TO THE OR FOR BILATERAL KNEE REVISIONS. COMPONENTS WERE REMOVED AND THOROUGH I&DS WERE PERFORMED IN CONJUNCTION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS, AND PLACEMENT OF NEW COMPONENTS. PATIENT DID HAVE BILATERAL I&DS WITH POLY EXCHANGES ON (B)(6) 2025. AS SUCH, THE INSERTS LISTED ON THIS SUBMISSION WERE FROM THAT DATE. THE RIGHT KNEE SHOWED SIGNIFICANT HETEROTOPIC OSSIFICATION AROUND THE FEMORAL SLEEVE, SUGGESTING INFECTION ON XRAY, SO SURGEON TO CHOSE TO FASHION A STATIC SPACER UTILIZING LPS COMPONENTS TO TREAT THIS SIDE. THE LEFT SIDE APPEARED TO BE DOING BETTER, BUT SINCE HOSPITAL ADMISSION EARLIER THIS WEEK ALSO BEGIN TO SWELL. WHEN CHECKING FIXATION OF THE FEMORAL COMPONENT, THE FEMORAL SLEEVE WAS ABLE TO BE REMOVED WITHOUT SIGNS OF BONY INGROWTH. LACK OF INGROWTH APPROXIMATELY SEVEN (7) WEEKS POST IMPLANTATION SUGGESTS THIS TOO WAS INFECTED. TIBIAL COMPONENT AND STEM WERE LEFT IN PLACE ON THE LEFT SIDE SINCE IT WAS WELL FIXED. NO DELAY NOR PATIENT HARM WAS NOTED. WHILE RESULTS ARE NOT YET AVAILABLE, SURGEON DOES BELIEVE INFECTION WAS STILL PRESENT AT THE TIME OF THIS PROCEDURE. THIS INFEC

  Patient problems: Extraskeletal ossification; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 22159216 ↗
• 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 21892736 ↗
• InjuryFeb 5, 2025Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED A LEFT KNEE REVISION FOR FAILED REVISION ARTHROPLASTY. ADAPTER BOLT AND ADAPTER BROKEN. ADAPTER WAS NOT ABLE TO BE REMOVED FROM UNIVERSAL SLEEVE. THE SURGEON TRIED FOR 90 MINUTES TO REMOVE THE ADAPTER FROM THE SLEEVE BUT WAS UNSUCCESSFUL. THE SURGEON DECIDED TO TRANSFER THE PATIENT TO ANOTHER FACILITY FOR TREATMENT AND MOST LIKELY A DISTAL FEMORAL REPLACEMENT. PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND HAD TO BE ABORTED AND PATIENT TRANSFERRED.

  Patient problems: Insufficient Information

  MAUDE report 21315145 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO THIGH PAIN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21294682 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS INSTABILITY. INTRAOPERATIVELY, IT WAS IDENTIFIED THAT THE TIBIAL BASE PLATE WAS LOOSE (INTERFACE NOT PROVIDED) AND HAD SUBSIDED. IT WAS ALSO NOTED THAT THE WELL-FIXED FEMUR WAS MALPOSITIONED/INTERNALLY ROTATED AND WAS EXPLANTED ALONG WITH THE TIBIAL TRAY AND INSERT. THE PATELLA COMPONENT WAS WELL-FIXED AND WAS RETAINED. REVISION TIBIAL TRAY AND REVISION FEMUR, WITH SLEEVE AND STEM FOR BOTH SIDE CONSTRUCTS WERE IMPLANTED, THERE WERE NO COMPLICATIONS REPORTED. NO PRODUCT INFORMATION WAS PROVIDED IN THE RECORDS FOR REVISED PRIMARY IMPLANTS OR RETAINED PATELLA. THE RECORDS DID PROVIDE A PARTIAL RECORD OF THE REVISION IMPLANTS PLACED DURING (B)(6) 2018 REVISION--THESE APPEAR TO BE ONLY FOR THE FEMUR SIDE OF THE KNEE (DEPUY FEMUR, AUGMENTS, SLEEVE, AND STEM, AS WELL AS DEPUY CEMENT). ON (B)(6) 2022, PATIENT'S LEFT KNEE WAS REVISED AGAIN TO ADDRESS SEVERE PAIN AND GROSS INSTABILITY. INTRAOPERATIVELY, THE WELL-FIXED FEMUR COMPONENTS WERE EXPLANTED FROM THE FEMORAL SLEEVE AND STEM, WHICH WERE WELL-FIXED AND RETAINED. AN S-ROM NOILES HINGED FEMUR WITH 2 FEMORAL AUGMENTS WAS IMPLANTED ALONG WITH 12MM THICK HINGED

  Patient problems: Joint Laxity; Pain

  MAUDE report 20657549 ↗
• InjuryAug 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANTED DEVICES BROKE AT JUNCTION BETWEEN FEMORAL SLEEVE AND FEMORAL STEM. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19959973 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO BE REINFECTED AFTER A 2-STAGE REVISION TKA. ALL COMPONENTS WERE REMOVED, AND A THOROUGH DEBRIDEMENT WAS PERFORMED. A SPACER WAS PLACED USING LPS COMPONENTS, INCLUDING THE PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND COATING THE PROSTHESIS WITH HIGH-DOSE ANTIBIOTIC CEMENT. NO DELAY OR PATIENT HARM WAS NOTED. THERE WAS NO ALLEGATION AGAINST ANY DEPUY COMPONENT; THEY WERE SIMPLY REMOVED DUE TO INFECTION. CEMENT WAS HOSPITAL-OWNED, SO LOT INFORMATION WAS UNAVAILABLE, BUT THE SURGEON'S ROUTINE INVOLVED USING DEPUY 2 WITH GENT FOR REVISION CASES. ALL PART AND LOT INFORMATION WAS COPIED AND PASTED DIRECTLY FROM OPTIMIZE AND WAS ACCURATE PER THAT SYSTEM. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19928255 ↗
• InjuryApr 3, 2024Migration; Migration

  IT WAS REPORTED THAT THE FOLLOWING IMPLANTS SUBSIDED. RIGHT LPS DISTAL FEMUR, UNIVERSAL FEMORAL SLEEVE, LPS ADAPTER AND UNIVERSAL STEM SUB-SITED LEAVING PATIENTS LEG SHORT ON THAT RIGHT SIDE. ALSO THE ATTUNE REVISION TIBIA, ATTUNE REVISION TIBIAL SLEEVE AND STEM WERE LOOSE. SURGEON EXPLANTED ALL IMPLANTS EXCEPT THE PATELLA. SURGEON REVISED AND REPLACED THE IMPLANTS. THERE WAS LOOSENING OF ALL IMPLANTS AT THE BONE TO CEMENT INTERFACE. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Physical Asymmetry

  MAUDE report 19033355 ↗
• InjuryJan 19, 2024Migration; Migration

  ADDITIONAL INFORMATION WAS RECEIVED: 1. WAS THIS A RIGHT KNEE CUSTOM LPS CONSTRUCT? -YES 2. WERE THERE TWO SEGMENTAL COMPONENTS UTILIZED WITH THE DISTAL FEMORAL CONSTRUCT? - NO 3. WAS THERE ANY INDICATION THAT THE FEMORAL SLEEVE FRACTURED? ANY ADDITIONAL INFORMATION THAT CAN BE PROVIDED TO CONFIRM THE CORRECT PRODUCT CODES WOULD BE APPRECIATED. THE PATIENT HEARD A CRACK AND AFTER THAT THE PATIENT HAD PAIN.

  Patient problems: Pain; Physical Asymmetry

  MAUDE report 18543923 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND HAD TO REMOVE IMPLANTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18074295 ↗
• InjuryAug 4, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE AFFECTED SIDE? RIGHT SIDE. B. WAS THERE ANY DEPUY CEMENT USED DURING THE SURGERY? IF YES, PLEASE PROVIDE PRODUCT DETAILS. YES CMW2G 40G REF NO. (B)(4), LOT NUMBER 8539213. C. WHICH IMPLANTS WERE LOOSE AND WHAT INTERFACE(S)? NONE WERE OBVIOUSLY LOOSE ON REMOVAL HOWEVER SHOWED LOOSENING ON BONE SCAN; ZONE 2 METAPHYSEAL SLEEVES WERE FIXED & REQUIRED SIGNIFICANT WORK TO LOOSEN. SOME LOOSENING AROUND ZONE 1 FEMUR CEMENT BONE INTERFACE. D. WHAT¿S THE CURRENT PATIENT OUTCOME? UNKNOWN AT THIS POINT. ONLY 2 WEEKS POST-OP. THE SURGEON WILL REVIEW AT 6 WEEKS.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 17459420 ↗
• InjuryJul 19, 2023Osseointegration Problem; Osseointegration Problem

  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: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 17350915 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INSTABILITY. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17044197 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION KNEE PLACED ON (B)(6) 2022 AND WAS WASHED OUT WITH PIN AND POLY EXCHANGED ON (B)(6) 2023. PATIENT HAD A STATIC SPACER PLACED DUE TO INFECTION. THERE WAS NO PATIENT HARM OCCURRED. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16269686 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HINGED KNEE PLACED STATUS POST KNEE SPACER ON (B)(6). PATIENT CAME BACK TO HOSPITAL WITH A WARM RED KNEE. SURGEON BELIEVED INFECTION WAS STILL PRESENT AND ALL COMPONENTS WERE REMOVED AND NEW SPACER WAS FASHIONED UTILIZING LPS COMPONENTS AS THE MCL WAS FOUND TO BE INCOMPETENT AT THE TIME OF SURGERY ON (B)(6). A DUAL SET WAS UTILIZED AND ANTIBIOTIC BEADS WERE PLACED ALONG WITH HIGH DOES ANTIBIOTIC CEMENT. CEMENT IS DEPUY 2 WITH GENT BUT LOT IS UNAVAILABLE AS IT IS HOSPITAL OWNED INVENTORY. DUE TO SHORT DURATION OF IMPLANTATION AND SUSPECTED INFECTION, NEITHER SLEEVE WAS INGROWN AT TIME OF REMOVAL. DOI: (B)(6),2022, DOR: (B)(6), 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14773852 ↗
• InjuryMay 18, 2022Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO THE FEMORAL ADAPTER BROKE OFF AND THE MORSE TAPER PART OF THE SLEEVE WAS STUCK IN THE SLEEVE AND THE COLLAR PORTION WAS FLOATING WITH SHARP EDGES IN THE FEMUR. THE METAL DEBRIS WAS THE REASON FOR REVISION. WE TOOK OUT ALL OF THE FEMORAL COMPONENTS AND PUT IN A DFR IMPLANT. THE SURGEON BELIEVES THE ADAPTER WASN¿T TIGHTEN/PUT TOGETHER CORRECTLY. UNKNOWN IF ANY LOOSENING. THERE IS A REPORTED SURGICAL DELAY OF 1.5 HOURS. DOI: (B)(6) 2015; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 14427268 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRA-OP EVENT OF SIGNIFICANT BLEEDING AT THE POSTEROLATERAL SIDE FROM THE POPLITEAL ARTERY AND THIS BLEEDING WAS STOPPED BY PACKING AND THE USE OF VASCULAR CLIPS, TOTAL BLOOD LOSS WAS 500 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13558737 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPEAT STAGE 2 INFECTION. DOI: (B)(6) 2014. DOR: (B)(6) 2014. THIS COMPLAINT IS LINKED TO (B)(4). IT WAS CREATED TO CAPTURE THE EVENT THAT WAS INDICATED ON NOTE (B)(4).

  Patient problems: Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Scar Tissue; Unspecified Infection; Wound Dehiscence

  MAUDE report 13548836 ↗
• InjuryJan 7, 2022Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  REVISION OF S-ROM FEMORAL COMPONENTS AND RETENTION OF MBT TIBIA. FAILURE OF FEMORAL COMPONENTS, UNCEMENTED COMPONENTS HAD BEEN CEMENTED IN AND FEMORAL STEM SNAPPED AT JUNCTION. REVISED TO DISTAL FEMORAL REPLACEMENT. DOI: UNKNOWN; DOR: (B)(6) 2021; UNKNOWN SIDE.

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

  MAUDE report 13190131 ↗