NA 86-7430Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295217916), received between Aug 10, 2017 and Apr 2, 2025 — classified as 32 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2025; AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21755007 ↗
• InjuryJan 30, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR FEMORAL LOOSENING. ALL FEMORAL COMPONENTS LOOSE. THE ENTIRE FEMORAL CONSTRUCT WAS LOOSE. IT CAME OUT WITH A FEW TAPS WITH CEMENT STILL STUCK TO THE FEMORAL COMPONENTS AND NO VISIBLE INGROWTH ON THE SLEEVE. SO, IT WAS LOOSE AT BOTH THE CEMENT-BONE AND IMPLANT-BONE INTERFACES. THE CEMENT MANUFACTURER WAS UNKNOWN AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21272680 ↗
• InjuryNov 11, 2024Migration; Migration

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT'S CONSEQUENCE WAS THE STEM PROTRUDING OUT OF THE ANTERIOR CORTEX.

  Patient problems: Insufficient Information

  MAUDE report 20652458 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT PATIENT HAD LOSS OF MOBILITY, DUE TO SUSPECTED HETEROTOPIC OSSIFICATION. THE PATIENT HAD A DEPUY TC3 RP REVISION KNEE. THE SZ 4 TC3 RIGHT FEMUR, 5 DEGREE BOLT, +2/-2 FEMORAL ADAPTOR, TC3 SZ 4 X 4 DISTAL AUGMENTS X2, TC3 SZ 4 X 4 POSTERIOR AUGMENT, 115 X 16 STEM AND TC3 RP SZ 4 X 12.5 INSERT WERE EXPLANTED. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 20645731 ↗
• InjuryFeb 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSE FEMORAL COMPONENTS. UNKNOWN SURGICAL DELAY. DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE

  Patient problems: Insufficient Information

  MAUDE report 18695184 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18654990 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2019. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17480576 ↗
• 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 17135090 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION TKR AS PART OF A SECOND STAGE DUE TO INFECTION. PATIENT HAS PRESENTED TO DR DAVID LIU AND UNDERGONE A POLY EXCHANGE AND WASHOUT. AT THIS STAGE, ON OPENING THE KNEE, THE KNEE WAS OBVIOUSLY PUSSY AND INFECTED. THE KNEE WAS WASHED OUT AND THE POLY BEARING EXCHANGED. SAMPLES TAKEN AT THIS STAGE ARE POSITIVE FOR BACTERIA (SENSITIVE STRAIN). A DECISION WAS MADE TO GO BACK INTO THE KNEE AND REMOVE ALL COMPONENTS AS PART OF A TWO STAGE PROCEDURE. ON OPENING THE KNEE IT APPEARED RELATIVELY ANGRY BUT NOT OVERTLY PUSSY. THE COMPONENTS WERE REMOVED, THE TISSUE DEBRIDED AND A TEMPORARY "KIWI" SPACER IMPLANTED (ATTUNE PS FEMUR AND AN ATTUNE PS RP INSERT) AS PART OF THE TEMPORARY SPACER. THESE WILL BE REMOVED IN DUE COURSE AND EXCHANGED FOR A REVISION SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 15973897 ↗
• InjurySep 2, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  SECOND REVISION COMPLETED DUE TO LOOSENING. FEMORAL COMPONENT WAS LOOSE. FEMORAL COMPONENT, FEMORAL STEM AND TIBIAL BEARING REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15348319 ↗
• InjuryAug 11, 2022Fracture; Fracture

  LITIGATION RECORD RECEIVED. LITIGATION ALLEGES FRACTURE BETWEEN TIBIAL STEM AND TIBIAL BASEPLATE RESULTING TO PAIN AND INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Adhesion(s); Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15209109 ↗
• InjuryOct 5, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12575674 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE FOLLOWING: 1. WAS THE CEMENT MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PRODUCT AND LOT NUMBERS. NO, PALACOS CEMENT WAS USED IN THE PREVIOUS OPERATION. 2. IT WAS MENTIONED IN THE EVENT DESCRIPTION THAT THE PATIENT HAD A REVISION OF HER RIGHT KNEE BY MR (B)(6) AT THE (B)(6) HOSPITAL ON THE (B)(6) 2019. DID THIS REVISION INVOLVE EXPLANTATION OF DEPUY PRODUCTS? IF SO, WAS THIS REVISION REPORTED? (IF THIS REVISION HAS BEEN PREVIOUSLY REPORTED PLEASE PROVIDE THE PC # IF KNOWN). NO, IT WAS A COMPETITOR KNEE REPLACEMENT THAT WAS REVISED. 3. IT WAS INDICATED THAT LOOSENING WAS DUE TO INFECTION. CAN YOU PLEASE ADVISE THE LOOSENING COMPONENT/S AND LOOSENING INTERFACE? THE FEMORAL AND TIBIAL COMPONENTS WERE LOOSE AT THE BONE CEMENT INTERFACE AROUND THE DISTAL FEMUR AND PROXIMAL TIBIA, THERE WAS ALSO SOME LOOSENING AROUND THE FEMORAL SLEEVE. 4. WAS SURGERY TIME EXTENDED? IF YES, WHAT WAS THE DURATION OF THE DELAY? AS THIS WAS A REVISION PROCEDURE THERE WAS NO EXTENSION TO THE SURGICAL TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 12235676 ↗
• InjuryJul 20, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL AND FEMORAL COMPONENT AT THE BONE TO CEMENT & CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. TIBIAL COMPONENT LOOKED LOOSE ON X-RAY. DURING PROCEDURE FEMORAL IMPLANTS WERE LOOSE AS WELL. RIPPED OUT ALL COMPONENTS WITH THE EXCEPTION OF 35 ROUND PATELLA. DOI: (B)(6) 2014, DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12196042 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT RECEIVED A SECOND LEFT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, REMOVAL OF FIBROUS TISSUE, AND PATELLAR TENDON REPAIR. ALL PRODUCTS WERE REVISED WITH THE EXCEPTION OF THE PATELLAR COMPONENT, WHICH WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR FEMORAL COMPONENT AND UNIVERSAL SLEEVE, DEPUY TIBIAL TRAY, STEM, AND INSERT, AND DEPUY CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017 (PATELLA). DOI: (B)(6) 2018 (COMPETITOR CEMENT, INSERT, TIBIA AND FEMUR - CAPTURED IN PC-(B)(4)). DOR2: (B)(6) 2019 LEFT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain

  MAUDE report 12010180 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SURGEON SUSPECTED AN UNDERLYING INFECTION HAS BEEN THE CAUSE OF ALL THE REVISIONS PERFORMED. AFFECTED SIDE IS LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Swelling/ Edema

  MAUDE report 11887169 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN LCS REVISION DUE TO LOOSENING, INFECTION AND FRACTURE (LOOSENING AND FRACTURE ARE UNSPECIFIED). DOR: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10726929 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TKR WHERE A STRYKER KNEE WAS UTILIZED. THIS KNEE WAS LATER REVISED TO A STRYKER REVISION. ON THE (B)(6) 2015 THE STRYKER REVISION KNEE WAS REVISED TO A PFC TC3. PATIENT HAS PRESENTED WITH A PAINFUL AND STIFF KNEE, WITH A LIMITED RANGE OF MOTION. BONE SCANS SHOW AN UPTAKE AROUND THE FEMORAL COMPONENT INDICATING A POSSIBLE LOOSE FEMORAL COMPONENT. A DECISION WAS MADE TO REVISE THE FEMORAL COMPONENT AND BEARING ON (B)(6) 2020. ON OPENING THE KNEE, THE FEMORAL COMPONENT WAS NOT OVERTLY LOOSE AND DID REQUIRE A LITTLE WORK TO REMOVE. IT WAS, HOWEVER CONSIDERED TO BE LOOSE. A DECISION WAS MADE TO CONVERT THE TC3 FEMUR TO AN S ROM HINGED KNEE (ALLOWING MORE MOBILITY) WHILE LEAVING THE REVISION TIBIAL TRAY IN SITU.

  Patient problems: Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10581848 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO MCL RUPTURE. REVISED FEMORAL COMPONENT AND TIBIAL POLY TO A SROM HINGE. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10291879 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED STAGE 1 OF A TWO-STAGE REVISION OF THE RIGHT KNEE TO TREAT PAIN, SWELLING, WALKING DIFFICULTY, AND PRURITIS SECONDARY CHRONIC INFECTION PROGRESSING TO SEVERE SEPSIS. UPON ENTERING THE JOINT, THE SURGEON ENCOUNTERS AND REMOVED GROSS PURULENCE FROM THE JOINT. SIGNIFICANT SYNOVITIS AND INFECTED TISSUE WERE DEBRIDED. ALL COMPONENTS WERE EXPLANTED AND REPLACED WITH DEPUY PRODUCTS AND COMPETITOR CEMENT X 5, AND STIMULAN ANTIBIOTIC BEADS. THE PATIENT WAS IMPLANTED WITH DEPUY PRODUCTS UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT WAS PLACED ON 6-WEEK IV ANTIBIOTICS. STAGE TWO REVISION IS SCHEDULED FOR 6 WEEKS, PENDING CLEARANCE OF INFECTION. DOI: (B)(6) 2016 (PATELLA). DOI: (B)(6) 2018 (INSERT, TIBIAL AND FEMORAL COMPONENTS). DOE: (B)(6) 2018 (WOUND DEBRIDEMENT). DOE: (B)(6) 2019 (DECOMPRESSION). DOR: (B)(6) 2019 (INSERT EXCHANGE). DOE: (B)(6) 2019 (WOUND DEHISCENCE REPAIR). DOR: (B)(6) 2020 (STAGE 1 REVISION). RIGHT KNEE.

  Patient problems: Edema; Fever; Itching Sensation; No Code Available; Pain; Sepsis; Unspecified Infection

  MAUDE report 10247598 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT KNEE BONE DECOMPRESSION TO TREAT PAIN AND WALKING DIFFICULTY SECONDARY TO HETEROTOPIC OSSIFICATION. INTRAOPERATIVELY, THE SURGEON REMOVED ANTERIOR SUPRAPATELLAR BONE SPURS AND ADHESIONS AND PERFORMED A SYNOVECTOMY. ALL COMPONENTS WERE WELL-FIXED AND RETAINED. THE PATIENT RECEIVED AN ANTERIOR ADDUCTOR CANAL NERVE BLOCK CATHETER FOR POSTOPERATIVE PAIN RELIEF. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATHOLOGY OF THE EXCISED TISSUE WAS BENIGN, AND NO INFECTION WAS IDENTIFIED. NO COMPONENTS WERE REVISED. DOI: (B)(6) 2016 (PATELLA), DOI: (B)(6) 2018 (INSERT, TIBIAL AND FEMORAL COMPONENTS), DOE: (B)(6) 2018 (WOUND DEBRIDEMENT), DOE: (B)(6) 2019 (DECOMPRESSION), RIGHT KNEE.

  Patient problems: Adhesion(s); Edema; Extraskeletal ossification; No Code Available; Pain

  MAUDE report 10247505 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVES A RIGHT KNEE SUPERFICIAL INCISION AND DEBRIDEMENT TO TREAT PAIN, SWELLING, AND PURULENT DRAINAGE SECONDARY TO POSTOPERATIVE SUPERFICIAL CUTANEOUS ABSCESS. RADIOGRAPHIC IMAGING IDENTIFIES A WELL-FIXED AND STABLE TC3 REVISION KNEE. THE PROCEDURE WAS DONE IN BY A WOUND CARE SPECIALIST. THE PATIENT IS TO CONTINUE ORAL ANTIBIOTIC TREATMENT. NO PRODUCTS WERE REVISED. DOI: (B)(6) 2016 (PATELLA), DOI: (B)(6) 2018 (INSERT, TIBIAL AND FEMORAL COMPONENTS), DOE: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Abscess; Edema; Fluid Discharge; Impaired Healing; No Code Available; Pain

  MAUDE report 10247204 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PREVIOUSLY, A DISTAL FEMUR REPLACEMENT HAD BEEN CARRIED OUT ON (B)(6) 2020 WITH ASEPTIC LOOSENING AND DESTRUCTION OF THE DISTAL FEMUR. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Dyspnea; Heart Failure; Low Blood Pressure/ Hypotension; No Code Available; Weakness

  MAUDE report 9925012 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO CHRONIC INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9874275 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9129544 ↗