LPS 1987-27-114Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295079408), received between Jun 29, 2017 and Apr 14, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE, SWAPPED LPS UNIVERSAL POLY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24876669 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY SWAP DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23361605 ↗
• InjuryApr 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: INSTABILITY AND POLY DISASSOCIATION.

  Patient problems: Joint Laxity

  MAUDE report 19166625 ↗
• InjuryJan 29, 2024Fracture; Fracture

  PATIENT WAS REVISED DUE TO THE IMPLANT (POLY) BROKE, HAD TO REMOVE FROM PATIENT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18597041 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE INITIAL SURGERY ON (B)(6) 2022. AFTER SEVERAL WEEKS, THE PATIENTS INCISION STARTED TO OPEN BACK UP. SURGEON WAS PLANNING TO REPAIR THE SOFT TISSUE WHILE CLEANING OUT THE KNEE. HE IS GOING TO EXCHANGE THE POLY DURING THE CLEANING PROCESS. HE OPTED TO DOWNSIZE THE POLY FROM A XSMALL 14MM INSERT TO A 12MM INSERT. HE FELT THIS WOULD GIVE HIM A LITTLE MORE ROOM TO CLOSE THE WOUND. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Wound Dehiscence

  MAUDE report 16583115 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14594111 ↗
• InjuryJan 24, 2022Fracture; Fracture

  FRACTURE OF LPS INLAY RIGHT SIDE. DOI: UNKNOWN, DOR: (B)(6) 2022, RIGHT SIDE. A SURGICAL DELAY WAS NOT REPORTED.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 13333269 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC WAS CREATED TO CAPTURE THE EVENT ON (B)(6) 2020. MEDICAL RECORDS NOTE THE PATIENT HAD PAIN IN RIGHT KNEE, EFFUSION, INFLAMMATION. THE PATIENT HAD AN ULTRASOUND AND AN ASPIRATION DONE, AND IS TO CONTINUE PHYSICAL THERAPY. AWARENESS DATE: (B)(6) 2021. DOI: (B)(6) 2019 (TIBIAL TRAY), (B)(6) 2019 (TIBIAL INSERT). (B)(6) 2020 (FEMORAL COMPONENT), DOE: (B)(6) 2020. THIS COMPLAINT WAS LINKED TO (B)(4). THIS WAS CREATED TO CAPTURE THE EVENT HAPPENED (B)(6) 2020 AS STATED ON AEI NOTE A-(B)(4).

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 13154342 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY EXCHANGED AND WASHED OUT WAS DONE BY THE SURGEON. DOI: UNKNOWN DOR: (B)(6), 2021 RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12893288 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. WASHOUT AND POLY EXCHANGE WAS DONE. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12336837 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF KNEE BEING TOO TIGHT AND HAVING TROUBLE FLEXING THE KNEE. SURGEON DID SOME SOFT TISSUE WORK AND REPLACED THE RIGHT LPS X-SMALL DISTAL FEMORAL IMPLANT AND THE LPS X-SMALL 14MM INSERT. REPLACED WITH A RIGHT XX-SMALL FEMORAL IMPLANT AND A LPS XX-SMALL 14MM INSERT. NO LOOSENING REPORTED. NO DELAY TO SURGERY. DOI: (B)(6) 2017, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 11689449 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY AND HINGE PIN EXCHANGE FOR INFECTION OF LEFT TOTAL KNEE REPLACEMENT. ORIGINAL SURGERY DATE WAS (B)(6) 2019 AT (B)(6).

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

  MAUDE report 11332024 ↗
• InjuryJan 20, 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 11200951 ↗
• InjuryJul 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LPS INSERT DISASSOCIATED FROM TIBIAL TRAY. A REVISION FROM 14MM TO 26MM WAS PERFORMED. DOI: (B)(6) 2019; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8793180 ↗
• InjuryApr 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PLEASE SEE BELOW REGARDING PRODUCT COMPLAINT (REVISION OF DISTAL FEMORAL REPLACEMENT): BUSINESS UNIT: DEPUY SYNTHES, DATE J&J BECAME AWARE: (B)(4) 2019 DATE OF EVENT: (B)(6) 2019, NAME OF REPORTER: (B)(6), HOSPITAL NAME: (B)(6) HOSPITAL. PRODUCT NAME, PRODUCT CODE: LPS DSTL FEM COM LOPROF XSM RT, 198714105. LPS POR FEM STEM 16.5DIAX150, 198716215. LPS UNIV TIB HIN INS XSM 14MM, 198727114. LOT/BATCH/EXP: AWAITING FOR INFORMATION. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? NO. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? FAILED IMPLANTS 1 MONTH POST OP. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? YES. PATIENT HAD TO SUBMIT TO ANOTHER SURGERY TO REMOVE FAILED IMPLANT AND RE-DO SURGERY. WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY. N/A. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? NO. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: ON X-RAY IT WAS VISIBLE INSERT DISLOCATION AND LOOSENING OF FEMORAL COMPONENT (INFORMATION GIVEN BY THE SURGEON).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8536917 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8375529 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS SEPSIS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8175451 ↗
• InjurySep 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6903418 ↗
• InjuryJul 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2017 DUE TO RIGHT KNEE PAIN, SWELLING, REDNESS AND DRAINAGE FOR 3 DAYS, FEVER, AND DECREASED RANGE OF MOTION. PATIENT HAD PREVIOUSLY HAD RIGHT KNEE REVISION SURGERY ON (B)(6) 2017. PATIENT HAS A COMPLICATED AND LONG SURGICAL HISTORY OF RIGHT KNEE. I&D AND REVISION OCCURRED ON (B)(6) 2017 DUE TO INFECTION. AT TIME OF REVISION THE SURGEON NOTED COPIOUS AMOUNTS OF OBVIOUS FRANK PUS WITHIN THE KNEE JOINT SPACE. DEVITALIZED TISSUE AND INFECTED TISSUE WAS SEEN THROUGHOUT. THOROUGH DEBRIDEMENT AND IRRIGATION WAS PERFORMED. MULTIPLE PRODUCTS WERE EXPLANTED AND REPLACED. AT 2 WEEK POST-OP ASSESSMENT ON (B)(6) 2017 PATIENT SHOWS NO SIGN ON INFECTION. THE RIGHT KNEE WOUND IS CONTINUING TO HEAL WITH SOME ERYTHEMA SURROUNDING THE INCISION WHICH APPEARS TO BE SOMEWHAT FROM THE WOUND VAC PLACEMENT, WHICH HAS BEEN REMOVED. THE SWELLING OF THE RIGHT KNEE HAS DECREASED SUBSTANTIALLY.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Infection

  MAUDE report 6731533 ↗
• InjuryJun 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6678723 ↗