NA 1294-53-215Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295026266), received between Sep 20, 2018 and Dec 5, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT UNIVERSAL FEM SLV DIS POR 31MM, SIGMA FEM ADAPTER NEUTRAL BOLT, AND AN UNKNOWN KNEE FEMORAL ADAPTOR WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED A TC3 DEPUY PROSTHESIS WHERE, DURING A POST-OPERATIVE PERIOD, ABUNDANT METALLOSIS WAS OBSERVED IN THE KNEE WITHOUT NOTICEABLE WEAR OF THE POLYETHYLENE. UPON EXTRACTION, ABNORMAL ROTATIONAL MOVEMENT WAS DETECTED BETWEEN THE FEMORAL SHIELD AND THE METAPHYSEAL SLEEVE, WHICH ARE TYPICALLY JOINED BY AN IMPACTED MORSE CONE SYSTEM. THIS MOVEMENT WAS IDENTIFIED AS THE SOURCE OF METAL DEBRIS. THE FEMORAL COMPONENT REMAINED HELD BY THE KEEL IN THE FEMORAL DIAPHYSIS, BUT THE EPIPHYSEAL PART OF THE IMPLANT EXHIBITED ROTATIONAL MOBILITY RELATIVE TO THE FEMUR. THE NEUTRAL BOLT AND ASSOCIATED PARTS APPEARED VISUALLY SEALED. THE PROSTHESIS WAS CHANGED.

  Patient problems: Foreign Body Reaction

  MAUDE report 23728383 ↗
• InjuryJul 12, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE SURGEON HAD TO CANCEL THE PATIENT TODAY FOR A KNEE REVISION SURGERY DUE TO A DELIVERY IMPLANTS PROBLEM. THE DELIVERY NOTE WAS NOT CONFORM. THE PATIENT HAD TO BE WAKEN UP. THE CUSTOMER RECEIVED DUPLICATE TIBIAL WEDGES BUT NOT FEMORAL SLEEVES.

  Patient problems: Insufficient Information

  MAUDE report 17308984 ↗
• InjurySep 15, 2022Fracture; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Fracture; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  HCP IS REPORTING A FRACTURE OF KNEE-TEP´S FEMORAL SLEEVE EXTENSION RIGHT SIDE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. UNKNOWN KNEE.

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

  MAUDE report 15426728 ↗
• InjuryJul 25, 2022Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IMPLANTATION OF AN LPS KNEE PROSTHESIS: XSM FEMUR AND FEMOR LPS + 10 MM ADAPTER (REF WITHOUT INTRAOPERATIVE COMPLICATION. DETECTION IN CONSULTATION OF A ROTATION DISORDER OF THE FEMUR, WHICH WAS NOT PRESENT ON THE INTRAOPERATIVE PICTURES RELATED TO A MISMATCH OF THE MORSE CONE (EITHER BETWEEN THE SLEEVE AND THE ADAPTER OR BETWEEN THE ADAPTER AND THE FEMUR). MAJOR ROTATION DISORDER IN EXTERNAL ROTATION OF THE FEMUR WITH SEVERE ALTERATION OF THE FLEXION AXIS OF THE LEG. SURGICAL REVISION FOR REPLACEMENT OF ADAPTER AND FEMORAL IMPLANT (SAME MANUFACTURER, SAME SIZES). NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 15099223 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11456087 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS PREVIOUS DATES OF SURGERY AS FOLLOWS: (B)(6) 2019 (PRIMARY IMPLANTATION), (B)(6) 2020 (FIRST REVISION), (B)(6) 2021 (POLY INSERT REVISION) AND (B)(6) 2021 (THIRD REVISION. HARDWARE WAS PLACED AND OR EXCHANGED ON THESE DATES. DER'S WERE SUBMITTED EACH TIME. PATIENT HAD RETURNED HOME AND WAS DOING WELL. PATIENT HAS A BAD FALL AND LACERATED HIS KNEE TRANSVERSELY. PATIENT WAS TREATED AT ANOTHER FACILITY. AFTER A FEW WEEKS PATIENT WAS BROUGHT TO THE ER BY HIS DAUGHTER WERE PATIENT WAS SEEN AND HAD AN OPEN WOUND. SURGEON BELIEVED THERE WAS GROSS CONTAMINATION OF THE JOINT AND CHOSE TO REMOVE ALL COMPONENTS. A NEW SPACER WAS PLACED AND DEPUY CEMENT WAS USED BUT IT IS HOSPITAL OWNED SO DO NOT HAVE PART OR LOT INFORMATION. DOI: (B)(6) 2019 (PRIMARY IMPLANTATION); (B)(6) 2020 (FIRST REVISION); (B)(6) 2021 (POLY INSERT REVISION); (B)(6) 2021 (THIRD REVISION). DOR: (B)(6) 2021, RIGHT KNEE. THIS REPORT CAPTURES THE EVENT AND PRODUCTS INVOLVED FOR (B)(6) 2021.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall; Laceration(s); Wound Dehiscence

  MAUDE report 11437208 ↗
• InjuryOct 22, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMUR, SLEEVE AND STEM AT THE BONE TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. TC3 FEMORAL ADAPTOR BOLT BROKE IN THE PATIENT. FEMUR WAS STILL CONNECTED TO SLEEVE BUT COULD WOBBLE FEMORAL COMPONENT AND KEEP SLEEVE/STEM STILL. PATIENT HAD SIGNIFICANT METAL DEBREE IN SYNOVIUM. TIBIAL COMPONENTS REMAINED IN PATIENT. REPLACED TC3 WITH LPS DISTAL FEMUR. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10723005 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED CONFIRMING THE INFECTION. IT WAS STATED THAT THERE WAS A CULTURE GROWN FROM THE RETRIEVED SPECIMENS THAT ARE LIKELY TO HAVE LEAD TO THE COMPONENT LOOSENING (BUG TYPE NOT CONFIRMED).

  Patient problems: Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Unspecified Infection

  MAUDE report 10567487 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON HAD TO REVISE AN SIGMA TC3 AND MBT REVISION TIBIA DUE TO PATIENT DISCOMFORT AND INSTABILITY. SURGEON REMOVED ALL EXISTING IMPLANTS AND PERFORMED REVISION WITHOUT ANY INCIDENT.

  Patient problems: Discomfort; No Code Available

  MAUDE report 8623626 ↗
• InjuryOct 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF PFC TC3 COMPONENTS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7934783 ↗
• InjurySep 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNK; DOR: (B)(6) 2018 UNK KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7895340 ↗