LPS 1987-27-316Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295079590), received between Oct 17, 2018 and Dec 2, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND I & D OF RIGHT KNEE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20820339 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT THE INITIAL PROCEDURE ON (B)(6) 2022 (RECEIVED AN S-ROM NOILES ROTATING HINGE KNEE). THE PATIENT FELT HIS KNEE "GIVE WAY", FOLLOWED BY SIGNIFICANT PAIN. UPON INVESTIGATION IT WAS DISCOVERED THAT THE "BOSS" FOR THE SLEEVE ATTACHMENT ON THE FEMORAL COMPONENT HAD BROKEN RESULTING IN FAILURE OF THE CONSTRUCT. THE PATIENT UNDERWENT REVISION SURGERY AND THE DAMAGED FEMORAL COMPONENTS WERE REMOVED AND REVISED TO AN LPS DISTAL FEMORAL REPLACEMENT. THE RETRIEVED IMPLANTS WERE SENT TO THE BIO-ENGINEERING DEPARTMENT AT (B)(6) HOSPITAL AS PER STANDARD PROTOCOL HERE IN (B)(6). IF OTHER, DESCRIBE: N/A, IF OTHER, DESCRIBE : REVISION KNEE SURGERY., PATIENT STATUS/ OUTCOME / CONSEQUENCES : YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PAIN, INFLAMMATION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE : X-RAYS, REVISION SURGERY, OTHER INFORMATION : N/A, IS THE PATIENT PART OF A CLINICAL STUDY : UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF : NONE, DEVICE IN POSSESSION

  Patient problems: Fall; Inflammation; Joint Laxity; Pain

  MAUDE report 15566819 ↗
• InjurySep 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  TKJR REVISION, MR. (B)(6); (B)(6), (B)(6) 2019; PRIMARY SURGERY DATE UNKNOWN: PRIOR REVISION (B)(6) 2016. JNJ REPRESENTATIVE PRESENT FOR THE CASE; AS PER SURGEON, PATIENT REPORTED PAIN AND FEELINGS OF INSTABILITY. ON PREOPERATIVE ASSESSMENT THE CONSTRAINT OF THE CURRENT HINGE IMPLANTS APPEARED TO HAVE ¿LOOSENED¿ - MORE MOVEMENT THAN WOULD BE EXPECTED OF A HIGHLY CONSTRAINED KNEE. ON REMOVAL OF THE LINER THERE APPEARED TO BE FLUID WITHIN THE POST IF THE INSERT - BETWEEN THE TITANIUM PIN AND POLYETHYLENE. THE OTHER COMPONENTS WERE WELL FIXED. THE LINER WAS EXCHANGED AND A NEW HINGE PIN INSERTED. NO DETAILS AVAILABLE. JNJ REPRESENTATIVE DOES NOT HAVE THE OTHER IMPLANT DETAILS OR THE DETAILS OF THE HINGE PIN REMOVED. THERE ARE NO X RAYS OR IMAGES AVAILABLE. TISSUE SAMPLES WERE TAKEN TO RULE OUT INFECTION. MALE PATIENT AGED (B)(6) YEARS, DOB: (B)(6).

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9086910 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT KNEE. IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGED WERE PERFORMED.

  Patient problems: No Code Available; Pain

  MAUDE report 7975986 ↗