LPS 1987-27-014Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295079347), received between Aug 30, 2017 and May 15, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAINFUL KNEE DUE TO POSSIBLE INFECTION. DOI: UNKNOWN DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 25190859 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IRRIGATION AND DEBRIDEMENT DONE FOR INFECTION WITH REPLACEMENT OF MODULAR COMPONENTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18088511 ↗
• InjuryAug 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED FOR DISLOCATION. A POLY SWAP WAS PERFORMED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 17434086 ↗
• InjuryJun 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PROSTHESIS HINGE OF THE TOTAL KNEE RUPTURED. SURGICAL REVISION TO REPLACE THE HINGE. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17070748 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. NO OTHER INFORMATION AVAILABLE. ORIGINAL DATE OF IMPLANTATION WAS UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16140759 ↗
• MalfunctionJan 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE LPS POLY POST WAS BROKEN. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16101597 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AMPUTATION: THE PATIENT RECEIVED AN ABOVE THE KNEE AMPUTATION DUE TO SIGNIFICANT PAIN, INFECTION, SWELLING, DRAINING, LYMPHEDEMA AND INABILITY TO AMBULATE. UPON ENTERING THE JOINT, THE CONSTRUCT WAS NOTED TO BE GROSSLY LOOSE AND INFECTED. THE AMPUTATION WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2017, DOR: (B)(6) 2021, UNKNOWN KNEE. THIS COMPLAINT IS ALSO LINKED TO (B)(4) WHERE THE TIBIAL TRIAL WAS REPORTED. ANOTHER PC IS LINKED TO THIS COMPLAINT UNDER (B)(4) WHERE THE EVENT HAPPENED IN BETWEEN APR 2017 - MAR 2019.

  Patient problems: Ambulation or Postural Difficulties; Fluid Discharge; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13549619 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT INSERT WAS INSERTED ON (B)(6) 2021 AND FEMUR INSERTED ON (B)(6) 2021. SURGEON DECIDED TO DO AN I&D AND EXPLORATION OF KNEE DUE TO UNEXPLAINED PAIN AND POSITION OF PATIENT, EVEN HAD SUSPICION SEPSIS OF HIP DUE TO PATIENT PRESENTATION, HYPER FLEXED AND EXTERNALLY ROTATED. HIP ASPIRATION WAS NEGATIVE. FEMORAL COMPONENT WAS REMOVED AS IT APPEARED THAT EXTERNAL ROTATION WAS INCREASED RELATIVE TO WHERE IT HAD BEEN PLACED AT THE PREVIOUS PROCEDURE. AN INSERT 2MM THINNER WAS USED AS FULL EXTENSION WAS NOT OBTAINED PRIOR TO SURGERY. NO INDICATION OF INFECTION WERE PRESENT IN THE KNEE, HOWEVER SPECIMENS WERE SENT FOR CONFIRMATION. DOI: (B)(6) 2021 (TIBIAL INSERT), (B)(6) 2021 (FEMORAL), DOR: (B)(6) 2021, RIGHT KNEE. THIS COMPLAINT IS RELATED TO (B)(4) WHICH REPORTS THE FIRST REVISION.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13250915 ↗
• InjuryAug 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. REPLACED POLY INSERT AND SEGMENT. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10471430 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEMUR WAS REVISED TO A FULLY COATED STEM AND DISTAL FEMUR REPLACEMENT TO GAIN STABILITY. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10311310 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS CHRONIC INFECTION. POLY EXCHANGE WAS PERFORMED BY SURGEON. DOI: (B)(6) 2019. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10080124 ↗
• InjuryMay 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT RUPTURED HER EXTENSOR MECHANISM AND DISLOCATED HER IMPLANT. THE JOINT LINE NEEDED TO BE RAISED SO THE FEMORAL COMPONENT WAS REMOVED AND RE-IMPLANTED WITH SMALLER SEGMENTS. THE TIBIAL INSERT DISLOCATED FROM THE MBT REV TRAY. DOI: (B)(6) 2019. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10039135 ↗
• InjuryJan 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. PERFORMED I&D OF KNEE AND SWAPPED POLY AND HINGE PIN. USED STIMULAN TO AID IN RIDDING INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9653449 ↗
• InjuryDec 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO CHRONIC PATELLA DISLOCATION. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9525937 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A DRAINING WOUND. DOING AN I&D, LINER EXCHANGE TODAY. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9098984 ↗
• InjuryJul 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS POLY DISLOCATION OUT OF THE TIBIA DUE TO SOFT TISSUE LAXATION AND LOOSENING OF THE UNKNOWN COMPONENT AT UNKNOWN INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2016; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8816109 ↗
• InjuryJan 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AND POLY WAS REPLACED.

  Patient problems: No Code Available

  MAUDE report 8237941 ↗
• InjuryOct 5, 2018Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  SURGEON REVISED THE FEMORAL SLEEVE AND FEMORAL STEM SO THAT HE COULD GET A THICKER POLY FOR JOINT STABILITY. SURGEON REVISED THE FEMORAL SLEEVE, FEMORAL PRESSFIT STEM AND THE HINGE INSERT AND WAS SATISFIED WITH THE PATIENT STABILITY. SURGEON RETAINED THE DISTAL FEMUR IMPLANT, 40MM SEGMENT AND 10MM ADAPTOR ON THE FEMORAL SIDE AND HE RETAINED THE MBT REVISION TIBIA, TIBIAL SLEEVE AND UNIVERSAL FLUTED STEM ON THE TIBIAL SIDE. DOI: (B)(6) 2018; DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Joint Laxity; Not Applicable

  MAUDE report 7938586 ↗
• InjuryApr 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ANTIBIOTIC SPACER IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7446147 ↗
• InjuryMar 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS KNEE INFECTION. DOI: (B)(6) 2018, DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7365893 ↗
• InjuryAug 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT BONE TO IMPLANT INTERFACE. LOOSENING WAS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6830448 ↗