LPS 1987-14-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10603295078708), received between Sep 6, 2017 and Jul 27, 2026 — classified as 57 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented post revision total knee arthroplasty with an improperly tracking patella. Femoral components was exchanged to a smaller femur, thus shortening overall the distance of the construct and creating less tension on her quadriceps mechanism. A lateral release was also performed in conjunction with an extensive repair or her medial tissues. This resulted in a better tracking patellar and should result in more proper function. LPS Adapter had been placed on (b)(6) 2026 and LPS distal femur and insert had been placed on (b)(6) 2026. No allegation was made against any component. The patella implant but was well fixed and left in place.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right knee.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50025124 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25827805 ↗
• InjuryMar 5, 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 INFECTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21530238 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DRAINING, SURGEON ELECTED TO WASHOUT AND CHANGE MODULAR PARTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 20353136 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO BE REINFECTED AFTER A 2-STAGE REVISION TKA. ALL COMPONENTS WERE REMOVED, AND A THOROUGH DEBRIDEMENT WAS PERFORMED. A SPACER WAS PLACED USING LPS COMPONENTS, INCLUDING THE PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND COATING THE PROSTHESIS WITH HIGH-DOSE ANTIBIOTIC CEMENT. NO DELAY OR PATIENT HARM WAS NOTED. THERE WAS NO ALLEGATION AGAINST ANY DEPUY COMPONENT; THEY WERE SIMPLY REMOVED DUE TO INFECTION. CEMENT WAS HOSPITAL-OWNED, SO LOT INFORMATION WAS UNAVAILABLE, BUT THE SURGEON'S ROUTINE INVOLVED USING DEPUY 2 WITH GENT FOR REVISION CASES. ALL PART AND LOT INFORMATION WAS COPIED AND PASTED DIRECTLY FROM OPTIMIZE AND WAS ACCURATE PER THAT SYSTEM. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19928228 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DRAINAGE POST SURGERY AND ELEVATED LABS INDICATIVE OF INFECTION. COMPONENTS WERE REMOVED AND A SPACER WAS MADE UTILIZING LPS COMPONENTS. NO DELAY WAS EXPERIENCED NOR PATIENT HARM OCCURRED. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19828792 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2024 , AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19468604 ↗
• InjuryApr 25, 2024Degraded; Naturally Worn; Degraded; Naturally Worn

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: LOOSE FEMORAL STEM. AT REVISION THE STEM TRUNNION SHOWED FRETTING AND CORROSION. THE BORE OF THE FEMORAL COMPONENT SHOWED FRETTING AND CORROSION.

  Patient problems: Insufficient Information

  MAUDE report 19180374 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  .

  Patient problems: Pain

  MAUDE report 18806507 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PERIPROSTHETIC FRACTURE OF IMPLANTS, NEW LPS WAS IMPLANTED. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 18543412 ↗
• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS COMPLAINING ON THIGH PAIN, SURGEON WAS WORRIED ABOUT LACK OF BONE GROWTH WITHIN THE FEMORAL STEM PROSTHESIS. UPON INSPECTION, THE ENTIRE PROSTHESIS WAS REMOVED FROM THE FEMORAL SIDE AND A CEMENTED BOWED STEM WAS IMPLANTED. A LARGER INSERT WAS ALSO TRAILED AND THEN INSERTED. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18392976 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THAT THERE WAS DELAY IN SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 18369252 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPTIC KNEE. THE LPS POLY & LPS DISTAL FEMORAL COMPONENT WERE REMOVED. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D). IMPLANTED NEW LPS POLY X-SMALL 23 MM & LPS X-SMALL DISTAL FEMORAL COMPONENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17669693 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO SEPTIC RIGHT KNEE. LPS POLY & LPS DISTAL FEMORAL COMPONENT WERE REMOVED. AN I&D WAS PERFORMED IN THE (B)(6) 2023 PROCEDURE FOR THE PURPOSE OF TREATING A SEPTIC KNEE. IMPLANTED NEW LPS POLY X-SMALL 23MM & LPS RIGHT X- SMALL DISTAL FEMORAL COMPONENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17662516 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO REPORTS OF SURGICAL DELAYS.

  Patient problems: Adhesion(s); Discomfort; Joint Contracture; Loss of Range of Motion

  MAUDE report 17540202 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED FOR INSTABILITY REPORTED DURING PRE-OP DIAGNOSIS. THE LPS INSERT THAT WAS FOUND TO HAVE A DAMAGED TIBIAL POST WAS REMOVED AND REPLACED. THE LPS FEMUR WAS ALSO REMOVED & REPLACED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16386053 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE INSERTED ON 2 DIFFERENT DATES AS A PARTIAL REVISION WAS PERFORMED ON THE SECOND DATE, (B)(6) 2021. A DER WAS SUBMITTED AT THAT TIME. FIRST 3 ITEMS LISTED WERE LEFT FROM (B)(6) 2020 PROCEDURE, THE REST WERE PLACED IN (B)(6). PATIENT COMPLAINED OF TIBIAL PAIN. XRAYS APPEARED TO HAVE LUCENCIES ON THE TIBIAL SIDE SO A TIBIAL SIDE REVISION WAS PLANNED. INSERT AND FEMORAL COMPONENT WERE REMOVED FOR EXPOSURE, THEN TIBIAL TRAY AND STEM WERE REMOVED, BUT THE TIBIAL SLEEVE WAS FOUND TO BE WELL FIXED. THE SURGEON WANTED TO SHORTEN THE ADAPTER ON THE FEMORAL SLEEVE AND WHEN TRYING TO REMOVE THE ADAPTER THE FEMORAL SLEEVE AND STEM WERE EXTRACTED. AT THIS POINT, A TIBIAL AND FEMORAL REVISION WERE PERFUMED UNEVENTFULLY. THERE WAS NO PATIENT HARM. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15526009 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL CAUSING AN OPEN DISLOCATION OF THE DISTAL FEMORAL REPLACEMENT. THE POLY, PIN AND THE BUMPER WERE CHANGED. THE DISTAL FEMORAL COMPONENT WAS NOT REMOVED. THERE WAS NO REPORTED LOOSENING AND SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 15197826 ↗
• InjuryJul 25, 2022Migration; 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 15099353 ↗
• InjuryMay 17, 2022No Apparent Adverse Event; No Apparent Adverse Event

  AN INCOMPLETE SHORT-TERM-LOANER-SET WAS FIRST RESERVED FOR ANOTHER CUSTOMER, BUT THE ORDER WAS CANCELLED. UNFORTUNATELY, WHEN THE NEW ORDER FOR ANOTHER CUSTOMER CAME, ORTHOKIT-STAFF MISSED TO RESEND THE INCOMPLETE MESSAGE. AT NEW CUSTOMER´S FACILITY THE PATIENT WAS ALREADY UNDER ANESTHESIA WHEN THE MISSING IMPLANT WAS NOTICED. THE SURGICAL PROCEDURE WAS NOT PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14416790 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO THE INFECTION. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14218696 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION KNEE SURGERY IN (B)(6) OF 2020. PATIENT APPEARED IN THE EMERGENCY ROOM WITH AN INFECTED TOTAL KNEE. SURGEON REMOVED DISTAL FEMUR AND INSERT AND PERFORMED AN IRRIGATION AND DEBRIDEMENT AND REPLACED THE PARTS REMOVED WITH THE SAME SIZES BUT NEW IMPLANTS. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14013364 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2021; DOR: (B)(5) 2021 RIGHT SIDE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Bone Fracture(s); Fall; Pain

  MAUDE report 13632827 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRA-OP EVENT OF SIGNIFICANT BLEEDING AT THE POSTEROLATERAL SIDE FROM THE POPLITEAL ARTERY AND THIS BLEEDING WAS STOPPED BY PACKING AND THE USE OF VASCULAR CLIPS, TOTAL BLOOD LOSS WAS 500 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13558739 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED SECONDARY TO PAIN. DOI: (B)(6) 2020, DOI: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13023462 ↗