LPS 1987-25-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295079149), received between Aug 16, 2018 and Feb 24, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REMOVING A PROXIMAL TIBIAL REPLACEMENT DUE TO CEMENTED STEM FRACTURE BREAK. UPON REMOVAL THE SURGEON INDICATED AN INCREASED AMOUNT OF POLYETHYLENE WEAR WHICH IN TURN CREATED METALOSIS IN THE JOINT. THE SURGEON BELIEVES THE POLY WEAR MAY HAVE LEAD TO THE FAILURE. DOI: (B)(6) 2015, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Bone Fracture(s); Foreign Body Reaction

  MAUDE report 24429274 ↗
• InjuryDec 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE STEM COMPONENTS WERE LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THERE ARE NO ALLEGATION AGAINST THE REPORTED DEVICES. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. PALACOS CEMENT WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 18290792 ↗
• InjuryAug 4, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE DFR COMPONENT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17457918 ↗
• InjuryOct 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE LPS CEMENTED STRAIGHT STEM BROKE, RESULTING IN REVISION SURGERY. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15680992 ↗
• InjuryOct 3, 2022Fracture; Fracture

  REVISION OF A RIGHT LPS FEMORAL REPLACEMENT AND STEM. PATIENT HAD FRACTURE THE FEMORAL STEM COMPONENT OF THE LPS. NO FALL REPORTED BY THE PATIENT, HE CLAIMS HE JUST FELT THE KNEE BECOME LOOSE OR WOBBLY. NO INFECTION PRESENT AT THE TIME OF THE PROCEDURE. STANDARD SPECIMENS FOR A REVISION TAKEN. PRIMARY SURGERY DONE ON (B)(6) 2020.

  Patient problems: Insufficient Information

  MAUDE report 15529965 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON CONVERTED DISTAL FEMORAL REPLACEMENT TO TOTAL FEMUR BECAUSE THE PATIENT FELL AND FRACTURED PROXIMALLY FEMUR. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 12358792 ↗
• InjuryNov 10, 2020Fracture; Fracture

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT HAS REPORTED WITH A FRACTURED LPS IN SITU, 1.5CM BELOW STEM COLLAR. THE LAST OPERATION - 2017 FOR CUP REVISION ONLY, LPS ALREADY IN SITU. IT IS UNKNOWN IF THE PRIOR REVISION WAS FOR DEPUY PRODUCTS.

  Patient problems: No Code Available

  MAUDE report 10815945 ↗
• InjuryApr 28, 2020Fracture; Fracture

  REVISION OF AN LPS DISTAL FEMUR DUE TO IMPLANT BREAKAGE THAT TOOK PLACE YESTERDAY. THE PATIENT IS AN (B)(6) YEAR OLD FEMALE. TIMELINE: (B)(6) 2017 - THE INITIAL FRACTURE HAPPENED - THE PATIENT WAS TREATED CONSERVATIVELY UNTIL (B)(6) 2018. (B)(6) 2018 ¿ THE PATIENT RECEIVED AN LPS DISTAL FEMUR REPLACEMENT DUE TO THE FRACTURE NOT HEALING AND ALSO HAVING AN ARTHRITIC KNEE. (B)(6) 2020 - THE PATIENT, AT HOME, STOOD UP TO CLOSE THE CURTAINS AND HEARD/FELT A SNAP AS THE IMPLANT BROKE. (B)(6) 2020 ¿ KNEE REVISED WITH ANOTHER LPS DISTAL FEMUR AND ORIGINAL IMPLANTS RETRIEVED FOR ANALYSIS. I REMEMBER SUPPORTING THE INITIAL PROCEDURE IN (B)(6) 2018 AND BOTH THE SURGEON AND I RECALL AN ISSUE WITH THE CEMENT AT THE TIME ¿ AFTER INJECTING THE CEMENT INTO THE DISTAL FEMORAL SHAFT, HE STRUGGLED TO GET THE IMPLANT IN AND HAD TO SCRAPE SOME CEMENT OUT OF THE FEMUR ¿ THE SURGEON THINKS IT IS POSSIBLE THIS JEOPARDIZED THE FINAL FIXATION AND CONTRIBUTED TO THE FAILURE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10007135 ↗
• InjuryFeb 28, 2020Loss of or Failure to Bond; Use of Device Problem; Malposition of Device; Loss of or Failure to Bond; Use of Device Problem; Malposition of Device

  IT WAS REPORTED THAT THE DFR WAS CEMENTED IN FOR PERI PROSTHETIC FX ON (B)(6) 2019. FEMORAL COMPONENT BECAME LOSE AT STEM CEMENT/ FEMORAL SHAFT INTERFACE. UPON EXAMINATION, COMPONENT STEM ROTATED WITHIN FEMORAL SHAFT. COMPONENT WAS EXPLANTED ON (B)(6) 2020 AND A NEW DFR WITH PORUS STEM WAS IMPLANTED. STEM LOOKED WELL FIXED. DOI: (B)(6) 2019. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9769723 ↗
• InjuryDec 26, 2019Fracture; Fracture

  DEPUY SYNTHES DISTAL FEMORAL REPLACEMENT REVISED. REASON FOR REVISION WAS BROKEN STEM.

  Patient problems: No Code Available

  MAUDE report 9519550 ↗
• InjurySep 4, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A DEPUY LPS 10X100 CEMENTED STEM, PART CODE 198725110, LOT NUMBER A5JAP1 WAS BENT. THIS WAS EXPLANTED (B)(6) 2018 AT (B)(6). THIS IS CONSIDERED SERIOUS HARM DUE TO THE NEED FOR REVISION SURGERY, AND WILL BE REPORTED TO (B)(6). THE DEVICE IS AVAILABLE FOR INVESTIGATION. CEMENT MANUFACTURER IS UNKNOWN. DOI: UNKNOWN - DOR: (B)(6) 2018 (UNKNOWN SIDE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7841488 ↗
• InjuryAug 16, 2018Break; Material Twisted/Bent; Break; Material Twisted/Bent

  THE PATIENT HAD AN LPS PROXIMAL TIBIAL REPLACEMENT 3 YEARS AGO FOR OSTEOSARCOMA. SHE HAD A RECENT FALL AND X-RAY SHOWED THAT THE CEMENTED STEM WAS BENT. THE SURGEON BROUGHT HER BACK TO THE OR TO REVISE THE STEM. DURING THE REVISION SURGERY, THE STEM WAS REMOVED AND A LONGER, BIGGER CEMENTED STEM WAS IMPLANTED. THE SURGEON FEELS THAT THIS IMPLANT SHOULD NOT HAVE FATIGUED AND BENT THIS EARLY ON. OTHER PRIMARY IMPLANTS REMAINS INSITU (SROM FEMUR XSM, 31 FEM SLEEVE, 75X14 STEM, LPS PROX TIB, 35 AND 40MM SEGMENT. 10X100 CEMENTED STEM WAS EXCHANGED FOR 12X125 CEMENTED STEM. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION:REQUIRED REVISION SURGERY. ACTION TAKEN FOR PROCEDURE:BENT STEM AND CEMENT WAS REMOVED AND A LONGER, BIGGER CEMENTED STEM WAS IMPLANTED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Bone Fracture(s)

  MAUDE report 7788895 ↗