LPS 1987-27-312Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295079576), received between Nov 27, 2017 and Jul 23, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 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

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO DELAY, NOR ADVERSE EFFECTS.

  Patient problems: Unspecified Infection

  MAUDE report 19808644 ↗
• InjuryJul 21, 2023Fracture; Fracture

  REVISION OF A UNIVERSAL LPS INLAY BECAUSE OF INLAY FRACTURE INTO SEVERAL PIECES. DOI: (B)(6) 2022. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17371371 ↗
• InjuryDec 6, 2022Fracture; Fracture

  POLY INSERT WAS FRACTURED IN THE PATIENT. WILL REQUIRE REVISION. DOI: (B)(6) 2000. DOR: UNKNOWN. LEFT SIDE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 15923905 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE FOLLOWING: 1. WAS THE CEMENT MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PRODUCT AND LOT NUMBERS. NO, PALACOS CEMENT WAS USED IN THE PREVIOUS OPERATION. 2. IT WAS MENTIONED IN THE EVENT DESCRIPTION THAT THE PATIENT HAD A REVISION OF HER RIGHT KNEE BY MR (B)(6) AT THE (B)(6) HOSPITAL ON THE (B)(6) 2019. DID THIS REVISION INVOLVE EXPLANTATION OF DEPUY PRODUCTS? IF SO, WAS THIS REVISION REPORTED? (IF THIS REVISION HAS BEEN PREVIOUSLY REPORTED PLEASE PROVIDE THE PC # IF KNOWN). NO, IT WAS A COMPETITOR KNEE REPLACEMENT THAT WAS REVISED. 3. IT WAS INDICATED THAT LOOSENING WAS DUE TO INFECTION. CAN YOU PLEASE ADVISE THE LOOSENING COMPONENT/S AND LOOSENING INTERFACE? THE FEMORAL AND TIBIAL COMPONENTS WERE LOOSE AT THE BONE CEMENT INTERFACE AROUND THE DISTAL FEMUR AND PROXIMAL TIBIA, THERE WAS ALSO SOME LOOSENING AROUND THE FEMORAL SLEEVE. 4. WAS SURGERY TIME EXTENDED? IF YES, WHAT WAS THE DURATION OF THE DELAY? AS THIS WAS A REVISION PROCEDURE THERE WAS NO EXTENSION TO THE SURGICAL TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 12235728 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE KNEE WAS OPENED AND THE OLD SROM HINGED COMPONENTS REMOVED AND THESE WERE REPLACED WITH AN ATTUNE REVISION TRAY (AS FULLY POROCOATED TIB SLEEVES ARE AVAILABLE) A CROSSOVER ATTUNE LPS BEARING UTILIZED (AVAILABLE ON SAS) AND A FRESH S ROM HINGE IMPLANTED, ALONG WITH A NEW PATELLA COMPONENT. REMOVAL OF ALL COMPONENTS DUE TO FUNGAL INFECTION.

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

  MAUDE report 11705677 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO CHRONIC INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9874282 ↗
• InjuryNov 27, 2017Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE POLY POST ON THE LPS INSERT WAS ERODED OFF DUE TO SHUCK IN THE KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7061467 ↗