LPS 1987-13-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295078685), received between Oct 10, 2017 and Jan 12, 2026 — classified as 34 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Naturally Worn

  METALLOSIS CAUSED BY THE JUNCTION OF THE DFR IMPLANTS. MORE SPECIFICALLY, THE FEMORAL COMPONENT (MADE OF COBALT CHROME) AND THE SEGMENT (MADE OF TITANIUM), WHICH SEEMED TO HAVE CAUSED LYSIS AND INFECTION OVER TIME BECAUSE OF THE NEGATIVE IMPLANT WEAR. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction; Osteolysis; Unspecified Infection

  MAUDE report 24040322 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND SURGEON ELECTED TO REMOVE IMPLANTS AND FUSE KNEE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23369924 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. PARTS WERE REPLACED TO REDUCE BIOBURDEN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22649700 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTS IN ER WITH WHAT IS BELIEVED TO BE AN ACUTE INFECTION AND A RUPTURED PATELLA TENDON. SURGEON PERFORMS A THOROUGH I&D WITH COMPONENT EXCHANGE OF MODULAR COMPONENTS. ALL COMPONENTS WERE WELL FIXED AND ALIGNED. RESORBABLE ANTIBIOTIC BEADS ARE PLACED AND TENDON IS REATTACHED/ REPAIRED VIA SUTURE. NO PATIENT HARM NOR DELAY WERE NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS ALL WERE PERFORMING NORMALLY UNTIL THIS POINT. LOT INFORMATION IS NOT AVAILABLE AS THIS WAS NOT TRANSFERRED DURING THE MIGRATION FROM COMPASS TO OPTIMIZE. DOI: ON (B)(6) 2018, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22566045 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. THE SURGICAL DELAY IS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21410069 ↗
• InjuryOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2014, THE PATIENT RECEIVED A KNEE ENDOPROSTHESIS (PARTIALLY COUPLED SYSTEM) FOR LEFT KNEE IN (B)(6) 2015, THE TIBIAL COMPONENT AND THE INLAY WERE CHANGED TO INCREASE THE TENSION. ON (B)(6) 2021, THE PATIENT SUDDENLY EXPERIENCED PAIN IN THE LEFT KNEE WITHOUT ANY EXTERNAL INFLUENCE, WHICH IS WHY SHE VISITED THE HOSPITAL. AFTER A CT EXAMINATION, A DISLOCATED PERIPROSTHETIC FRACTURE WAS DETECTED MEDIALLY AT THE DISTAL FEMUR ON (B)(6) 2021, AS WELL AS A COLLAPSE OF THE FEMORAL PROSTHESIS AT THE LEVEL OF THE FRACTURE. IN THE YEARS 2015 TO 2020 THERE ARE ANNUALLY FINDINGS CONFIRMING THAT THERE HAVE NEVER BEEN ANY SIGNS OF LOOSENING OF THE PROSTHESIS.

  Patient problems: Joint Dislocation; Joint Laxity; Limb Fracture; Pain

  MAUDE report 20450391 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM. SURGEON INTENTIONALLY SHORTENED HER FEMORAL CONSTRUCT WHEN DOING SO TO ALLOW FOR INCREASED FLEXION. PATIENT FELT UNSTABLE AND WAS BROUGHT TO THE OR FOR INCREASED LENGTH. COMPONENTS WERE EXCHANGED WITHOUT DELAY OR PATIENT HARM. THERE ARE NO ALLEGATIONS AGAINST ANY COMPONENTS, ONLY FILING DUE TO THE EXCHANGE OF COMPONENTS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19906839 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: Joint Laxity

  MAUDE report 19230729 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION, WASH OUT AND SWAPPED COMPONENTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17951492 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STILL DRAINING AND SURGEON ELECTED TO WASH OUT AND CHANGE COMPONENTS THAT HE WAS ABLE TO. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 16417793 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DVT IN HER ARM FROM A PIC LINE POST OPERATIVELY. SHE WAS ANTICOAGULATED AND CAUSED A SWELLING IN HER KNEE. INCISION UNFORTUNATELY CAME OPEN DUE TO INCREASED SWELLING AND AN I&D WAS PERFORMED. SURGEON CHOSE TO EXCHANGE MODULAR COMPONENTS AT THE TIME OF SURGERY. NO PATIENT HARM OCCURRED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Wound Dehiscence

  MAUDE report 15804086 ↗
• InjuryOct 21, 2022Loss of or Failure to Bond; No Apparent Adverse Event; Loss of or Failure to Bond; No Apparent Adverse Event

  REVISION OF DEPUY TKR COMPONENTS FOR IMPLANT LOOSENING. LEFT KNEE. LOT NUMBERS NOT SOURCED. IMPLANTS DISCARDED. DOI: (B)(6) 2009, DOR (12TH): (B)(6) 2021. DOR (13TH): (B)(6) 2022.

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

  MAUDE report 15649687 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IMPLANTS REMOVED AND REPLACED DUE TO SUSPECTED INFECTION. IMPLANTS WERE PLACED ON 2 DATES PER THE RECORDS ON (B)(6) 2019 (FIRST 5 ITEMS LISTED) AND ON (B)(6) 2022. PATIENT EXPERIENCED REPEATED EFFUSIONS. SURGEON HAS SENT MULTIPLE ASPIRATIONS BUT NO CULTURES WERE NOT POSITIVE. CELL COUNTS AND LAB VALUES WERE ELEVATED, BUT NOT REACHING A LEVEL TO DIAGNOSE INFECTION. DURING THE PROCEDURE, 2 SEPARATE TISSUE SAMPLES WERE SENT TO PATHOLOGY, AND 3 AND 4 WBC/HPF WERE FOUND, AGAIN ELEVATED BUT NOT DEFINITIVE. SURGEON CHOSE TO REMOVAL ALL COMPONENTS AND REPLACE IN A ONE STAGE FASHION AFTER A THOROUGH DEBRIDEMENT AND IRRIGATION. ANTIBIOTIC BEADS WERE PLACED IN CANALS AND SURROUNDING SOFT TISSUES AND VANCOMYCIN WAS ADDED TO GENT CEMENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 15470347 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. THE FEMORAL COMPONENT AND INSERT WERE EXCHANGED. I&D WAS PERFORMED. THE LPS STEM, MBT TRAY, SLEEVE, AND STEM WERE LEFT IN SITU. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13930350 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REPORTED TO BFARM: "SUDDEN INCREASE OF PAIN IN THE LEFT KNEE JOINT AFTER A FALL EVENT."

  Patient problems: Fall; Pain

  MAUDE report 13720520 ↗
• 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 MRSA 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 13567754 ↗
• InjuryNov 4, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  A PHONE CALL WAS RECEIVED FROM A PATIENT TODAY. HE STATED THAT ON (B)(6) 2020, A PIECE BROKE WITHIN THE LPS AND A REVISION WAS DONE A COUPLE DAYS LATER. DOI: NOT INDICATED; DOR: NOT INDICATED; UNK KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Scar Tissue

  MAUDE report 12751105 ↗
• InjurySep 22, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION LPS FOR PATELLA SCARRING/CLUNKING AND PAIN - APPEARED TO BE TISSUE RUBBING ON POROUS COLLAR ON LPS STEM LPS REMOVED AND LPS WITH SLEEVE PUT IN. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Pain; Scar Tissue

  MAUDE report 12512995 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTED LPS STEM AT FEMUR HAS BEEN BROKEN. THE X-RAY SHOWED THAT THE IMPLANT AND BONE BOTH FRACTURED. DOR: (B)(6) 2021.

  Patient problems: Limb Fracture

  MAUDE report 12318732 ↗
• InjuryJun 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE DISTAL FEMORAL RESECTION AT THE CEMENT TO IMPLANT AND BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. SURGEON ELECTED TO REVISE THE FEMORAL COMPONENT. DOI: (B)(6) 2019 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12014172 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HINGE PIN WAS REMOVED AND NOT REPLACED. THE SURGEON PLACED AN ANTIBIOTIC SPACER IN THE KNEE. THE FEMORAL SLEEVE AND STEM WERE LEFT IMPLANTED.

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

  MAUDE report 11628946 ↗
• InjuryMar 23, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED LEFT KNEE REVISION OF THE STEM AND FEMORAL COMPONENT TO TREAT THIGH DISCOMFORT ASSOCIATED WITH LOOSENING OF THE COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. SURGEON SAID PATIENT HAD THEIR KNEE REVISED BACK ON (B)(6) 2020. SURGEON PREFORMED THE REVISION AND JUST EXCHANGED THE POLY FROM A 26MM TO 28MM. SURGEON DIDN'T HAVE ACCESS TO THE PREVIOUS PROCEDURE DATES PRIOR TO SURGEON REVISION. DOI: (B)(6) 2019 (STEM AND FEMORAL), DOI: (B)(6) 2020 (INSERT AND HINGE PIN), DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Discomfort

  MAUDE report 11554774 ↗
• InjuryJan 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS SUSPECTED INFECTION. PATIENT ALSO HAS A DISLOCATED PATELLA SO SURGEON CHOSE TO EXCHANGE MODULAR COMPONENTS AND ALSO CHOSE TO SHORTEN THE FEMORAL SIDE. A THOROUGH I&D AND A LATERAL RELEASE WERE PERFORMED. SURGEON ALSO PLACED ANTIBIOTIC BEADS. NO LOOSENING AND DELAY TO SURGERY REPORTED. DOI: (B)(6) 2018, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11200954 ↗
• InjuryJun 25, 2020Migration; Migration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL STEM AT THE BONE TO IMPLANT INTERFACE. THE FEMORAL IMPLANT SUBSIDED. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10196337 ↗
• InjuryDec 11, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS INCREASING PAIN, DECREASED RANGE OF MOTION, AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER AND DATE OF IMPLANTATION ARE UNKNOWN. PATELLA WAS WORN AND TIBIAL CONSTRUCT (UNKNOWN PART AND LOT NUMBER) REMAIN INSITU. FEMUR AND PATELLA WERE REVISED. DOI: UNKNOWN. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 9451884 ↗