LPS 1987-26-414Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295079293), received between Jan 24, 2018 and Apr 9, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS WITH DRAINING POST REVISION TKA THAT WAS TREATED WITH A STATIC SPACER FOR INFECTION. WHILE ASPIRATION PRIOR TO REIMPLANTATION WAS NEGATIVE FOR INFECTION, PATIENT NOW WAS POSITIVE FOR A FUNGAL INFECTION AND ALL COMPONENTS WERE REMOVED AN A NEW STATIC SPACER WAS PLACED IN CONJUNCTION WITH RESORBABLE ANTIBIOTIC BEADS LOADED WITH ANTIBIOTIC AND ANTIFUNGAL MEDICATION. NO DELAY NOR PATIENT HARM WAS NOTED. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24834917 ↗
• MalfunctionApr 15, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE PERFORMING A REVISION KNEE FUSION ON THE PATIENT, THE SURGEON REMOVED THE OLD CEMENTED COMPONENT AND DECIDED TO IMPLANT A PRESS FIT COMPONENT. AFTER REMOVING ALL TRACES OF THE PREVIOUSLY IMPLANTED CEMENT, THE SURGEON REAMED THE FEMORAL CANAL FIRST WITH FLEXIBLE IM REAMERS TO THE DESIRED SIZE, 15MM. THEN, THE SURGEON REAMED WITH SEQUENTIAL AML STRAIGHT REAMERS. BECAUSE THE PATIENT HAD LESS THAN DESIRED BONE DENSITY, THE SURGEON CHOOSE TO REAM LINE TO LINE OF THE IMPLANT SIZE CHOSEN. THE SURGEON REAMED TO A 15.5 AND CHOOSE TO IMPLANT A 15.5X125MM STEM. HERE IS THE PROBLEM, THE SURGEON WAS ABLE TO STICK THE COMPONENT IN AND PULL IT OUT EASILY WITH HIS FINGER. STEM, 16.5MM, WAS IMPLANTED PROPERLY. BECAUSE THIS COMPONENT FIT PROPERLY, THE SURGEON WAS ABLE TO PROCEED AND LOCK THE TIBIAL AND FEMORAL COMPONENT TOGETHER WITH NEW INTRACALRY SECTION AND SEGMENTAL COMPONENTS. IT WAS ALSO REPORTED THAT THERE WAS NON-CEMENTED LOOSENING OF THE LPS 15.5 POROUS STEM. SURGICAL DELAY WAS UNKNOWN. DOE: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106299 ↗
• MalfunctionMar 28, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE PERFORMING A REVISION KNEE FUSION ON THIS PATIENT. SURGEON REMOVED THE OLD CEMENTED COMPONENT AND DECIDED TO IMPLANT A PRESS FIT COMPONENT. AFTER REMOVING ALL TRACES OF THE PREVIOUSLY IMPLANTED CEMENT, THE SURGEON REAMED THE FEMORAL CANAL FIRST WITH FLEXIBLE IM REAMERS TO THE DESIRED SIZE, 15MM. THEN THE SURGEON REAMED WITH SEQUENTIAL AML STRAIGHT REAMERS. BECAUSE THE PATIENT HAD LESS THAN DESIRED BONE DENSITY, THE SURGEON CHOOSED TO REAM LINE TO LINE OF THE IMPLANT SIZE CHOSEN. SURGEON REAMED TO A 15.5 AND CHOOSE TO IMPLANT A 15.5X125MM STEM. LPS 15.5 POROUS STEM WAS LOOSE. HERE IS THE PROBLEM, SURGEON WAS ABLE TO STICK THE COMPONENT IN AND PULL IT OUT EASILY WITH FINGERS. THIS BEING UNACCEPTABLE AND CONFUSING TO SAY THE LEAST, SURGEON HAD TO CHOOSE THE NEXT SIZE LARGER STEM AND INSERT THIS STEM. THIS STEM, 16.5MM, WAS IMPLANTED PROPERLY WITH THE USE OF AND IMPACTION HANDLE AND MALLET. BECAUSE THIS COMPONENT FIT PROPERLY SURGEON WAS ABLE TO PROCEED AND LOCK THE TIBIAL AND FEMORAL COMPONENT TOGETHER WITH NEW INTRACALRY SECTION AND SEGMENTAL COMPONENTS. THE PATIENT WAS CLOSED IN THE USUAL FASHION. BECAUSE OF THE CONFUSION AS TO WHY THIS STEM DID NOT FIT, A

  Patient problems: Insufficient Information

  MAUDE report 18991053 ↗
• InjuryMay 9, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. PATIENT HAD A FALL AND AFTERWARDS EXPERIENCED INCREASING PAIN IN HER THIGH. A LOOSE FEMORAL STEM WAS SUSPECTED. FEMORAL STEM WAS REVISED UNEVENTFULLY. NO PATIENT HARM OCCURRED AND THE NEW PIN WAS USED IN THE DISTAL FEMORAL COMPONENT. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Inadequate Osseointegration; Pain

  MAUDE report 16896471 ↗
• MalfunctionSep 18, 2019Inaccurate Information; Inaccurate Information

  DURING AN LPS PROXIMAL FEMUR REPLACEMENT THE GUIDELINES IN THE SURGICAL TECHNIQUE WERE NOT DETAILED ENOUGH TO ENSURE CONFIDENT PREPARATION FOR A POROUS COATED STEM WITH MBT REVISION REAMERS THAT ARE PACKED ROUTINELY WITH THE LPS KIT. THERE IS A NB: IN THE SURGICAL TECHNIQUE TO CAUTION THAT THE MBT REVISION REAMERS ARE 0.4MM UNDERSIZED. THESE REAMERS ARE AVAILABLE IN WHOLE NUMBERS ONLY (12, 13 ETC). THE POROUS STEMS ARE AVAILABLE IN SIZES 12.5, 13.5 ETC. IT IS RECOMMENDED TO REAM FOR 0.5 MM PRESS-FIT OR LINE-TO-LINE IN SOFT BONE. DURING THIS CASE USING AN MBT REAMER, THE CANAL WAS PREPARED WITH A 16 MM MBT REAMER GIVING A 0.9 MM PRESS FIT WITH 16.5 MM STEM OR OVER-REAMED BY 0.1 MM FOR A 15.5 MM STEM. TO BE CAUTIOUS, A 15.5 MM STEM WAS THE FIRST CHOICE OF IMPLANT TO REDUCE RISK OF FRACTURE, THIS STEM WAS UNDERSIZED. THE FINAL DEFINITIVE IMPLANT SUCCESSFULLY IMPLANTED WAS A 16.5 STEM. THE NOTES IN THE SURGICAL TECHNIQUE WERE INADEQUATE TO CONFIDENTLY AND SUCCESSFULLY PREPARE THE FEMUR IN THE FIRST INSTANCE.

  Patient problems: Not Applicable

  MAUDE report 9084387 ↗
• InjurySep 6, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT FEMORAL CONSTRUCT "TURNED" INSIDE THE FEMORAL CANAL. WAS A PRESS-FIT LPS FEMORAL CONSTRUCT. LOOSE FEMORAL STEM FROM IMPLANT TO BONE INTERFACE. DOI: (B)(6) 2018. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7852804 ↗
• InjuryJan 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. (B)(6) 2017. (B)(6) 2018. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7214798 ↗