LPS 1987-06-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295078500), received between May 22, 2019 and Apr 23, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K040281, K071417); they may or may not involve this specific model.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER IN (B)(6) 2025 WITH BILATERAL INFECTED KNEES FROM AN ACUTE INFECTION IN THE PATIENTS BLOOD. IT AFFECTED BOTH THE KNEES WHICH HAD REV IMPLANTS IN AND BOTH THE SHOULDERS WHICH HAD NO IMPLANTS. PATIENT WAS WASHED OUT AND IMPLANT EXCHANGES TOOK PLACE ON 2 SEPARATE OCCASIONS AT A DIFFERENT FACILITY. PATIENT CAME INTO CLINIC FOR FOLLOW UP ON (B)(6) 2025 AND BOTH KNEES APPEARED TO STILL BE INFECTED. CULTURES SHOWED A SENSITIVE STREP. SURGEON ADMITTED THE PATIENT AND BILATERAL KNEE REVISIONS WERE PERFORMED IN A ONE STAGE FASHION TO INCLUDE THOROUGH IRRIGATION AND DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THIS WAS FROM AN ORGANISM IN PATIENT BLOOD THAT AFFECTED MULTIPLE JOINTS IN PATIENT'S BODY. DATE OF IMPLANTATIONS: RIGHT REVISION KNEE WAS (B)(6) 2016. NO INFORMATION WAS AVAILABLE WITH REGARD TO PRODUCTS EXPLANTED ON (B)(6) 2016. LEFT REVISION KNEE WAS (B)(6) 2023. NO INFORMATION AVAILABLE WITH REGARD TO PRODUCTS EXPLANTED ON (B)(6) 2023. ON (B)(6) 2025, AN I&D AND INSERT EXCHANGE TOOK PLACE FOR THE LEFT KNEE FOR HEMATOMAS, AND P

  Patient problems: Unspecified Infection

  MAUDE report 21890069 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED IN SURGEON'S OFFICE WITH SYMPTOMS OF AN ACUTE INFECTION. PATIENT WAS ADMITTED AND BROUGHT TO THE OR FOR REVISION OF MODULAR COMPONENTS, A THOROUGH IRRIGATION AND DEBRIDEMENT (I&D), AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY WAS EXPERIENCED AND NO PATIENT HARM WAS NOTED. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19374244 ↗
• InjuryOct 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO LEFT DISTAL FEMUR DISASSOCIATION FROM SLEEVE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18030816 ↗
• InjuryJul 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 15099306 ↗
• 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 (B)(6) INFECTION. THE PATIENT WAS PLACED ON IV ANTIBIOTICS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015, DOR: 12-AUG-2016, (LEFT KNEE).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 13567751 ↗
• 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 13558748 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AMPUTATION WAS DONE. DOI: (B)(6) 2015, DOR: (B)(6) 2016, UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 13549321 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPEAT STAGE 2 INFECTION. DOI: (B)(6) 2014; DOR: (B)(6) 2014; THIS COMPLAINT IS LINKED TO (B)(4). IT WAS CREATED TO CAPTURE THE EVENT THAT WAS INDICATED ON NOTE (B)(4).

  Patient problems: Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Scar Tissue; Unspecified Infection; Wound Dehiscence

  MAUDE report 13548837 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO FEMUR WAS USED. THIS IS AN UNCEMENTED DEVICE, HOWEVER CEMENT IS UTILIZED TO COAT THE SPACER FOR THE PURPOSE OF ANTIBIOTIC DELIVERY. BOTH SLEEVES SUBSIDED FROM THE ORIGINAL POSITION THEY WERE PLACED CONSIDERING THEIR POSITION ON X-RAY, HOWEVER IT WAS THE FEMORAL SIDE SLEEVE WAS MOVING AT THE TIME OF SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 12749940 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT THE IMPLANT TO BONE INTERFACE. SURGEON REPLACED ALL THE PARTS ON THE FEMUR AND LEFT THE TIBIA. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 12513588 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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

  MAUDE report 11280036 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10584200 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIA SLEEVES AT THE BONE TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. THE SURGEON PERFORMED ONE STAGE REVISION AS PATIENT ASPIRATION GREW OUT (B)(6). ALL COMPONENTS REMOVED AND REPLACED. CEMENT WAS OWNED BY HOSPITAL SO NO INFORMATION WAS AVAILABLE IN OUR RECORDS. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10522635 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. INSERT WAS CHANGED ON (B)(6) 2020. DOI: (B)(6) 2019; (B)(6) 2020 ( INSERT ONLY ), DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10304664 ↗
• InjuryApr 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, INFECTION, RESTRICTED TO LIMITED MOTION AND REDNESS. THE SURGEON REMOVED EVERYTHING AND PUT A SPACER IN. DOI: (B)(6) 2020; DOR: (B)(6) 2020; UNKNOWN KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain; Unspecified Infection

  MAUDE report 10007527 ↗
• InjuryDec 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE FEMORAL ADAPTER IS LOOSE. DOI: (B)(6) 2019; DOR: UNKNOWN; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9397987 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE PROXIMAL TO FEMORAL COMPONENT. REVISED LPS DISTAL FEMUR AND RETAINED MBT REVISION TIBIAL TRAY. NO EVIDENCE OF INFECTION PER INTRAOP FROZEN SECTION. DOI: (B)(6) 2019, DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8633441 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040281, K071417. One submission often covers many models, so check the product and lot details in each record.

• Z-0830-2013 · Jan 4, 2013 · Terminated
  LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct sever
• Z-0828-2013 · Jan 4, 2013 · Terminated
  LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct sever
• Z-0829-2013 · Jan 4, 2013 · Terminated
  LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct sever
• Z-0831-2013 · Jan 4, 2013 · Terminated
  LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct sever