NA 86-7416Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 10603295217831), received between Nov 10, 2017 and Aug 7, 2026 — classified as 97 injuries, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse 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 2026. Darthmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to pain and stiffness.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 50173059 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED A FALL POST TOTAL KNEE ARTHROPLASTY (TKA), RESULTING IN A TORN SURGICAL REPAIR AND DAMAGE TO THE QUADRICEPS MECHANISM. THE SURGEON DETERMINED THAT SHORTENING THE FEMORAL CONSTRUCT WOULD REDUCE TENSION ON THE REPAIR, LEADING TO REMOVAL OF THE FEMORAL COMPONENTS AND EXCHANGE OF THE PATELLAR COMPONENT TO A CEMENTED VERSION. ALL COMPONENTS WERE FUNCTIONING WELL PRIOR TO THE FALL, AND THERE WAS NO DELAY OR ADDITIONAL PATIENT HARM NOTED. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 24474313 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ PAIN/STIFFNESS DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED PROCEDURE RELATED: NO INFORMATION PROVIDED DATE OF EVENT: 15 SEP 2025. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL), SYNOVECTOMY.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 23325831 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (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: THE SIGMA TIBIAL SLEEVE, TIBIAL STEM, TIBIAL TRAY, AND TIBIAL INSERT WERE REVISED FOR INSTABILITY AND PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22668253 ↗
• 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 21892738 ↗
• MalfunctionApr 4, 2025Migration; Migration

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE TO ADDRESS SEVERE PAIN AND IMPLANT LOOSENING/MIGRATION OF THE TIBIAL TRAY. DATE OF IMPLANTATION: (B)(6) 2001. DATE OF ONSET: (B)(6) 2015. DATE OF REVISION: (B)(6) 2016 (LEFT KNEE). ON (B)(6) 2001, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY. ON (B)(6) 2015, THE PATIENT IS NOTED TO HAVE PAIN LOOSE TIBIA, MIGRATION/LOOSENING ¿ TIBIAL. DEFINITELY DEVICE RELATED. ON (B)(6) 2016, PATIENT NOTED TO HAVE SEVERE PAIN RELATED TO DEVICE, NOT RELATED TO PROCEDURE LEFT KNEE (PART/LOT PAGE 1 OF 1 DOTS: THE FOLLOWING KNEE ADVERSE EVENT HAS BEEN EDITED FOR (B)(6)). ON (B)(6) 2016, THE PATIENT HAD A REVISION LEFT TOTAL KNEE TO ADDRESS FAILED TIBIAL COMPONENT. THE INDICATIONS FOR SURGERY INCLUDE TIBIAL LOOSENING, FAILURE OF FIXATION. DURING THE PROCEDURE THE SURGEON OBSERVED THAT THE TIBIAL COMPONENT WAS GROSSLY LOOSE, AS THERE WAS DEBONDING FROM THE CEMENT BUT THE MEDICAL CEMENT HAD FAILED AND THE IMPLANT HAD TIPPED INTO VARUS. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE INCLUDING DEPUY PATELLA. (SURGERY PAGE 4,5 OF 5 (B)(4) CLINICAL NOTES AD 18 AUG 2023). ON MAY 2, 2018, MEDICAL RECORDS NOTE T

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 21771970 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OF LCS IMPLANTS WAS PERFORMED ON (B)(6) 2025 DUE TO PATIENT INFECTION. THERE WAS NO SURGICAL DELAY. NO CEMENT WAS USED.

  Patient problems: Unspecified Infection

  MAUDE report 21561125 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTED LEFT DISTAL FEMORAL REPLACEMENT. REMOVED CERTAIN IMPLANTS AND PERFORMED WASHOUT AND I&D. REPLACED CERTAIN IMPLANTS ALONG WITH SOME ANTIBIOTIC CEMENT. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21549872 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE. SURGEON SWITCHED THE FEMUR TO A HINGE CONSTRUCT DUE TO COLLATERAL LIGAMENT DEFICIENCIES. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 21057417 ↗
• InjuryDec 30, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q4 OF 2024. (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: REVISION DUE TO LOOSE FEMORAL COMPONENT (UNKNOWN INTERFACE) AND PAIN.

  Patient problems: Pain

  MAUDE report 21035108 ↗
• 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 20657494 ↗
• 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 PR

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 20567735 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTS WERE REMOVED DUE TO INFECTION. A SPACER WAS PLACED UTILIZING LPS COMPONENTS IN A DUAL SET UP FASHION IN CONJUNCTION WITH A THOROUGH I&D WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY NOR PATIENT HARM TOOK PLACE. NO ALLEGATION WAS MADE AGAINST ANY COMPONENTS AT THIS TIME, AS ALL WERE WELL FIXED AND WELL FUNCTIONING. FEMORAL SIDE HAD BEEN REVISED ON (B)(6) 2023 AND AGAIN ON (B)(6) 2024. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20426458 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION KNEE REPLACEMENT: REVISING ATTUNE CR RP CEMENTED. CONVERTED TO PS RP CEMENTED. DOI: (B)(6) 2024; DOE: (B)(6) 2024. ADDITIONAL EVENT DESCRIPTION: PRIMARY (MEDACTA) KNEE HAD INFECTION, REVISED TO SROM HINGE, PERSISTENT INFECTION, RV WASHOUT OF SROM HINGE.

  Patient problems: Unspecified Infection

  MAUDE report 19740706 ↗
• 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 (B)(6) 2020 PATIENT WAS TREATED AT (B)(6). 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 OF THE REVISION W

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

  MAUDE report 19173478 ↗
• InjuryApr 24, 2024Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED: NO SURGICAL DELAY IN EITHER CASE (THE FIRST LPS DFR, NOR THE REVISION LPS DFR) THE FAILURE OCCURRED AT THE SLEEVE/STEM CONNECTION. THE THREADS OF THE STEM BROKE OFF INSIDE THE SLEEVE.

  Patient problems: Insufficient Information

  MAUDE report 19172562 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PER THE SURGEON, THE PATIENT WAS INFECTED. THE SURGEON REMOVED ALL COMPONENTS AND PUT IN SPACER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18654972 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL TIBIA. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 18138721 ↗
• InjuryNov 8, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAS A LEFT TOTAL SIGMA KNEE WITH A LOOSE TIBIAL TRAY. THE SURGEON REVISED THE TIBIAL TRAY AND RETAINED THE WELL FIXED FEMUR AND PATELLA. THE TIBIAL SLEEVE DID NOT SEEM TO INGROW ON THE CONSTRUCT. DOI: (B)(6) , 2021 DOR: (B)(6) 2023 AFFECTED SIDE : LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18096625 ↗
• 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 17459416 ↗
• InjuryMay 12, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT COMES FOR FURTHER DISCUSSION REGARDING PAINFUL BILATERAL TOTAL KNEE ARTHROPLASTIES. THE PATIENT HAD A RIGHT TOTAL KNEE IN 2006 AND REVISION IN 2019. SHE HAD A LEFT TOTAL KNEE IN 2006, A REVISION IN 2019 AND A SCOPE DEBRIDEMENT IN 2020. THE PATIENT CONTINUES TO HAVE ONGOING PAIN AND DISCOMFORT IN BOTH OF THE KNEES. THE PAIN IS DAILY. IT IS STARTING TO LIMIT HER ACTIVITIES. SHE HAS GOOD RANGE OF MOTION. SHE HAS SOME SWELLING AT TIMES. SHE HAS SOME GRINDING AND POPPING IN BOTH KNEES. THE LEFT KNEE HURTS MORE OFTEN THAN THE RIGHT KNEE. SHE DID PREVIOUSLY DISCUSS REVISION SURGERY WITH SURGEON. SHE WOULD LIKE TO PROCEED WITH STAGED TKA REVISIONS, LEFT ONE FIRST. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16918612 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH METALLOSIS AT TAPER LOCK. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN SIDE.

  Patient problems: Foreign Body Reaction

  MAUDE report 16885431 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINS OF PAIN ON FEMORAL SIDE OF A REVISION KNEE THAT HAS AN SROM HINGE KNEE IN PLACE THAT SHOWS LUCENCY ADJACENT TO THE FEMORAL SLEEVE AND STEM. PATIENT WAS NOT OPERATED ON LOCALLY PER SURGEON SO NO INFORMATION ABOUT PREVIOUS IMPLANTS IS AVAILABLE. FEMORAL SIDE COMPONENTS WERE REMOVED. FEMUR WAS REMOVED WITH LITTLE FORCE HOWEVER THE SLEEVE WAS INGROWN AND HAD TO BE CUT OUT. A DISTAL FEMORAL COMPONENT WAS PLACED WITH STEM AND SLEEVE WITHOUT COMPLICATIONS. NO PATIENT HARM OCCURRED. DOI: UNKNOWN. DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16707115 ↗
• 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 16269683 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH A PAINFUL KNEE AND SCANS SHOWED THE IMPLANT WAS LOOSE BOTH THE FEMUR AND THE TIBIA AND THE PATIENT WAS EXPERIENCING INSTABILITY. NO INFECTION WAS FOUND. DOI: (B)(6) 2019. DOR: (B)(6) 2022. LEFT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14985788 ↗