LPS 1987-27-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295079439), received between Dec 18, 2017 and Nov 6, 2024 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. NO ISSUES WITH IMPLANTS OR POSITION. SURGEON STATED JOINT LINE WAS ELEVATED. DOI: (B)(6) 2016, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Muscular Rigidity

  MAUDE report 20624302 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: Joint Laxity

  MAUDE report 19230735 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. THE SURGEON PERFORMED I&D AND DETERMINED THAT THE INFECTION MIGHT BE DEEP. SO HE EXCHANGED THE POLY AND HINGE PIN AS WELL. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18921508 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17085883 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN AND DISCOMFORT IN HER KNEE. THE KNEE WAS REVISED WHERE THE SROM HINGE FEMORAL COMPONENT, THE UNIVERSAL FEMORAL SLEEVE, FEMORAL UNIVERSAL STEM AND THE LPS INSERT WERE EXPLANTED. THE MBT REVISION TRAY, MBT SLEEVE, AND UNIVERSAL STEM WERE LEFT IN SITU ON THE TIBIAL SIDE. A LPS DISTAL FEMORAL REPLACEMENT AND LLS CEMENTED STEM WERE IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: UNK. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Pain

  MAUDE report 15542777 ↗
• 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)(6) 2021; RIGHT KNEE.

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

  MAUDE report 13632821 ↗
• 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: Pain

  MAUDE report 12533134 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD A KNEE REVISION WITH RETENTION OF FEMORAL SLEEVE AND STEM WITH SROM HINGE PLACEMENT. AT THAT TIME, AN MBT REVISION TRAY WAS PLACED INTO A 29 SLEEVE WITH CEMENTED STEM. ON (B)(6) 2020, THE PATIENT HAD COMPLETE EXPLANT OF FEMUR AND TIBIAL COMPONENTS. PHYSICIAN STATES, THE PATIENT HAS "NEVER DONE WELL." INFORMATION REGARDING THE OTHER IMPLANTS NOT LISTED ARE NOT KNOWN TO THE REP. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10713278 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON REMOVED INSERT, DEBRIDED KNEE AND REIMPLANTED THE SAME SIZE INSERT. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10393239 ↗
• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE AND INFECTION. IRRIGATION & DEBRIDEMENT WAS DONE. NO OTHER INFORMATION AVAILABLE. DOI: UNKNOWN DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10367845 ↗
• InjuryDec 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INCISION WAS NOT HEALING APPROPRIATELY SO SURGEON DECIDED TO DO I&D WITH POLY EXCHANGE. INFECTION UNKNOWN AND UNAVAILABLE. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 9525759 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED LPS REVISION KNEE. SURGEON REMOVED THE SEGMENTS AND DISTAL FEMUR AND REPLACED WITH SIMILAR PARTS TO WHAT THEY TOOK OUT EXCEPT FOR A 5MM LONGER SEGMENT. SURGEON WASHED OUT EXTENSIVELY THE DISTAL FEMUR REGION OF THE LEG. DOI: (B)(6) 2018. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9383277 ↗
• InjuryDec 27, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DURING A PROCEDURE, I & D W/ TIBIAL INSERT EXCHANGE DONE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8200600 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HINGE PIN AND POLY WAS REMOVED, WOUND WAS WASHED OUT AND SAME PARTS WERE PUT BACK IN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8032995 ↗
• InjuryFeb 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED FOR POSSIBLE INFECTION. LINER SWAP AND I AND D WAS DONE. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7266315 ↗
• 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 7214814 ↗
• InjuryDec 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN IN THE KNEE. DOI: (B)(6) 2017; DOR: (B)(6) 2017; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7125919 ↗