NA 1294-53-225Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295026297), received between Oct 20, 2017 and Dec 11, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS LEFT DISTAL FEMUR REPLACEMENT DONE ON AN UNKNOWN DATE. PATIENT DISLOCATED THE KNEE AND BROUGHT IN FOR REVISION. THE FEMORAL COMPONENT WAS LOOSE SO A NEW DISTAL FEMORAL COMPONENT AND INSERT WERE IMPLANTED. THE TIBIAL COMPONENT WAS NOT LOOSE AND WAS LEFT IN PLACE. THERE WAS NO DELAY IN SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23783697 ↗
• 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, (B)(6): DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(6): DEVICE PROPERTY OF -->NONE,

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 20567710 ↗
• 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 20279449 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF TC3 DUE TO SIGNIFICANT INSTABILITY. MALPOSITIONING OF THE IMPLANTS CONTRIBUTED TO THIS DURING THE INITIAL CASE. INITIAL SURGERY DATE UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 19331643 ↗
• InjuryMay 8, 2023Off-Label Use; Off-Label Use

  IMPLANT RUPTURE AT THE FEMORAL STEM: RUPTURE AT THE CONNECTION BETWEEN THE STEM AND THE SLEEVE.

  Patient problems: Insufficient Information

  MAUDE report 16885805 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN I& D WITH A REVISION OF THE LEFT KNEE LPS HINGED INSERT TO TREAT PAIN AND SWELLING SECONDARY TO (B)(6) INFECTION. THE PATIENT WAS PLACED ON IV ANTIBIOTICS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2016. (LEFT KNEE).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 13567748 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AMPUTATION WAS DONE. DOI - (B)(6) 2015; DOR - (B)(6) 2016; UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 13549351 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF TOTAL LEFT KNEE REPLACEMENT ON SEPSIS AND LOOSENING. FRACTURE / LOOSENING OF THE FEMORAL BOLT SCREW. CONSEQUENCE ON THE PATIENT: PAIN +++, NO DEBRIS, DISPLACEMENT OF THE FEMUR. DOI: (B)(6) 2019; DOR: UNKNOWN; LEFT KNEE.

  Patient problems: Pain; Sepsis

  MAUDE report 12357966 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). MEDICAL RECORDS WERE REVIEWED TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, SYNOVITIS, TIBIAL INSERT WEAR, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN MANUFACTURER PRODUCTS WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED DURING THE REVISION. IT IS NOTED, AT THE END OF THE PROCEDURE, THE SURGEON REPORTED AN INTRAOPERATIVE DISTAL FEMORAL FRACTURE EXTENDING ABOUT 10 CM PROXIMALLY. THE FRACTURE WAS TREATED WITH 4 CERCLAGE WIRES AND NOTED TO BE STABLE. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, SWELLING, AND INFECTION. THE TIBIAL INSERT WAS EXCHANGED AND THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2020, 5-WEEK POST-OPERATIVE VISIT INDICATED SIGNIFICANT EFFUSION OF THE LEFT KNEE WITH MILD ERYTHEMA BUT NO OVERALL WARMTH. AFTER REVISION, THE PATIENT RECEIVED IV ANTIBIOTICS VIA A PICC LINE. THE PATIENT'S CRP WERE STILL ELEVATED COMPARED TO NORMAL, BUT WERE CONTINUING TO TREND DOWN. THIS PC CAPTURES THE EFFUSION AND IV ANTIBIOTICS ON (B)(6) 2020.

  Patient problems: Edema; Erythema; No Code Available

  MAUDE report 9748847 ↗
• InjuryOct 20, 2017Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR, SLEEVE AND STEM. LOOSENING INTERFACE OCCUR AT THE BONE TO IMPLANT. CEMENT MANUFACTURER IS FROM COMPETITOR.

  Patient problems: No Information

  MAUDE report 6965637 ↗