LPS 1987-06-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295078487), received between May 30, 2018 and Jul 23, 2024 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SYMPTOMS OF INFECTION. ALL COMPONENTS WERE REMOVED, A THOROUGH I&D PERFORMED AND A ACER WAS FASHIONED OF LPS COMPONENTS. NO DELAY NOR PATIENT HARM WAS NOTED. ALL COMPONENTS WERE WELL FIXED AND INGROWN. PATIENT DID HAVE A COMPONENT EXCHANGE WITH I&D PERFORMED ON (B)(6) 2024. DUE TO A FALL. (B)(4) WAS FILED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19809836 ↗
• InjurySep 13, 2023Difficult to Insert; Difficult to Insert

  FAILURE OF LPS MEDICAL RECORD WAS REVIEWED BY CLINICIAN. ON (B)(6) 2023, THE PATIENT WAS REVISED TO ADDRESS THE FEMORAL COMPONENT ROTATING AS THE DISTAL PART OF THE FEMORAL CONSTRUCT COULD ROTATE FREELY ON THE SLEEVE. THE SLEEVE AND SEGMENT COMPONENT REPORTED FOR IMPLANT TO IMPLANT FIT.

  Patient problems: Insufficient Information

  MAUDE report 17739250 ↗
• MalfunctionDec 6, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LPS METAPHYSEAL SLEEVE ADAPTOR WOULD NOT MORSE TAPER TO FEMORAL METAPHYSEAL SLEEVE. 0 ADAPTOR WOULD NOT MORSE TAPER HOWEVER THE +5 WAS MORSE TAPERED SUCCESSFULLY AND IMPLANTED. THERE WAS A SURGICAL DELAY OF TWO MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923309 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO SIGNIFICANT SCARRING AND HAD POOR QUAD FUNCTION. PATIENT HAS HAD MULTIPLE SURGERIES. PATIENT HAD A TC3 RP REVISION PLACED IN (B)(6) 2018, WHICH MANY ITEMS WERE REMOVED AND CONVERTED TO DISTAL FEMORAL REPLACEMENT ON (B)(6) 2021(FEMORAL SLEEVE AND STEM WERE RETAINED). FEMORAL SIDE WAS REVISED AND JOINT LINE WAS ELEVATED TO TRY TO ADJUST PATELLA POSITION AND IMPROVE QUAD FUNCTION. FEMORAL SIDE WAS UNCEMENTED. NO PATIENT HARM WAS OCCURRED. NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Unspecified Tissue Injury

  MAUDE report 15587637 ↗
• InjurySep 16, 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, 9-12-19(FIRST 5 ITEMS LISTED) AND 1-27-22. 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 15437337 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERSISTENT EFFUSION OF THE KNEE. THE SURGEON CHOSE TO DISTALIZE THE FEMORAL COMPONENT AS THERE WAS MILD LAXITY BUT DID NOT WANT THE JOINT LINE CHANGE TO NEGATIVELY IMPACT THE PATELLA FEMORAL FUNCTION. DOI: (B)(6) 2018; DOR: (B)(6) 2021 ; RIGHT KNEE.

  Patient problems: Joint Laxity; Swelling/ Edema

  MAUDE report 13118179 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED PAIN, ABNORMAL RADIOGRAPHIC EVALUATION INDICATING INTERVAL MIGRATION ANTERIOR CORTEX ABUTMENT OF THE PROXIMAL STEM OF THE FEMORAL COMPONENT. THIS IS NOTED TO POTENTIALLY CAUSE A FUTURE FRACTURE. NO FRACTURE IS INDICATED CURRENTLY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DOI: (B)(6) 2011, DOE: (B)(6) 2018, (RIGHT KNEE).

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 12533132 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS NO EXTENSION TO THE SURGICAL TIME.

  Patient problems: Fall; Limb Fracture; Pain

  MAUDE report 12131399 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS HAD MULTIPLE OPERATIONS. IMPLANT DATES RELATING TO THIS SURGERY ARE AS FOLLOWS: STEM, SLEEVE AND CABLE ON (B)(6) 2018. DISTAL FEMUR AND INSERT ON (B)(6) 2020. THIS COMPLAINT CAPTURES THE PATELLA TENDON RUPTURE REPAIR (B)(6) 2020. PATIENT HAD A PATELLA TENDON RUPTURE AFTER HER SURGERY ON (B)(6) 2020 WHICH WAS REPAIRED ON THE (B)(6) 2020 SURGERY. DOI: (B)(6)2021 ADAPTER; DOR: (B)(6)2021; RIGHT KNEE.

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

  MAUDE report 12041764 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DOING WELL BUT DEVELOPED A UTI. SUBSEQUENTLY, HER KNEE BEGAN TO SWELL AND GET "HOT". SURGEON ASSUME ACUTE INFECTION SO MODULAR COMPONENTS WERE EXCHANGE ALONG WITH A THOROUGH I&D AND PLACEMENT OF ANTIBIOTIC BEADS. THE COMPONENTS REMOVED WERE NON CEMENTED. DOI: (B)(6) 2021 DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 11843848 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. DATE OF IMPLANTATION. NOT SURE SORRY. B. LOT NUMBER: UNIVERSAL STEM 115X14MM FLUTED (867428) AND LPS XX-SM HINGE PIN. REFER IMAGE UPLOADED. C. PLEASE CONFIRM IF THE CEMENT WAS MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PART AND LOT NUMBERS OF THE CEMENT. NO STYKER.

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

  MAUDE report 11796214 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ARTHROFIBROSIS, DEVELOPED SEVERE HO AND COULD NOT STRAIGHTEN HER LEG. A THOROUGH DEBRIDEMENT TO INCLUDE ALL HO AND ALL IMPLANTS WERE REMOVED THEN REPLACED. DOI: (B)(6) 2020; DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Adhesion(s); Extraskeletal ossification; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10262438 ↗
• InjuryMar 13, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT ORIGINALLY HAD SIGMA REVISION COMPONENTS THAT WERE REVISED ON (B)(6) 2019 BECAUSE THE FEMORAL COMPONENT WAS INTERNALLY ROTATED WHICH LED TO POOR PATELLA TRACKING AND SUBLUXATION. ON (B)(6) 2019, AN LPS HINGED KNEE AND METAPHYSEAL SLEEVE WERE IMPLANTED TO ADDRESS THE PATELLA TRACKING ISSUE. SINCE THIS PROCEDURE, THE FEMORAL CONSTRUCT HAD SUBSIDED APPROXIMATELY 3CM. THESE COMPONENTS NEEDED TO BE REVISED TO RESTORE THE JOINT LINE. THE FEMORAL CONSTRUCT WAS REMOVED AND A COMPETITOR CONE WAS IMPLANTED ALONG WITH A 200MM CEMENTED LPS STEM, XSMALL LPS SEGMENTAL FEMUR AND 25MM SEGMENT. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9829984 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS REVIEWED. THE SURGEON NOTED THAT THE PATIENT EXPERIENCED EXPECTED ACUTE BLOOD LOSS ANEMIA POST-OPERATIVELY AND RECEIVED TWO UNITS OF PACKED RED BLOOD CELLS TO ADDRESS THE ISSUE. DOI: (B)(6) 2006; DOR #1: (B)(6) 2010; DOR #2: (B)(6) 2019; (RIGHT KNEE).

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9610792 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERIPROSTHETIC FRACTURE OF OPERATIVE LEG. DOI: (B)(6) 2019. DOR: (B)(6) 2019; RIGHT KNEE.

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

  MAUDE report 9267126 ↗
• MalfunctionMay 30, 2018Fitting Problem; Fitting Problem

  DER STATES THAT SLEEVE ADAPTER WOULD NOT LOCK TO SLEEVE. DOE: (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7553621 ↗

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-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
• 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-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-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