LPS 1987-27-118Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295079422), received between Nov 10, 2017 and Jul 14, 2025 — classified as 25 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION OF KNEE. SURGEON PERFORMED I&D WITH LINER REPLACEMENT. NO BROKEN PIECES OR SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22493777 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. UPON EXPLANT, IT WAS REALIZED THE STEM AND SLEEVE JUNCTION WAS BROKEN. SURGEON REPORTED A FALL PRIOR TO REPORTS OF INSTABILITY. THERE WAS LOOSENING OF SLEEVE AND SROM FEMUR AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 22423878 ↗
• InjuryApr 24, 2024Fracture; Fracture

  J-C HEALTH CARE LTD. RECEIVED ON 9 APRIL 2024 A DEMAND LETTER DATED(B)(6) 2024 PERTAINING TO A TOTAL KNEE REPLACEMENT WITH SIGMA IMPLANT. ACCORDING TO THE DEMAND LETTER, BACK IN 2019 PATIENT UNDERWENT A LT TKR IN (B)(6) (UNKNOWN IMPLANT) AND SUFFERED FROM INFECTION. THEREAFTER PATENT UNDERWENT SEVERAL INFECTION REVISIONS (ALSO IN RUSSIA) INCLUDING REMOVAL OF TIBIAL IMPLANT AND INSERTION OF SPACER, THAT DID NOT SOLVE THE INFECTION. DURING (B)(6) 2020 PATIENT WAS TREATED AT SHEBA MEDICAL CENTER IN ISRAEL. ON (B)(6) 2020 ((B)(4) CAPTURED FOR THE 1ST REVISION) PATIENT UNDERWENT A FIRST STAGE OF LT TKR REVISION AT (B)(6) DUE TO "INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL JOINT PROSTHESIS (LEFT)" DURING WHICH HER IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. THEREAFTER PATIENT WAS PLACED IN PLASTER CAST/BRACE AND KNEE FIXATION AND RECEIVED A LONG TERM SYSTEMIC ANTIBIOTIC TREATMENT UNDER LABORATORY MONITORING. AFTER 6 WEEKS OF ANTIBIOTIC TREATMENT WITH VANCOMYCIN AND LABORATORY MONITORING FOR ADDITIONAL 2 MONTHS, IT WAS FOUND THAT THERE WAS NO INFLAMMATION OF THE INFECTION FOLLOWING CESSATION OF THE ANTIBIOTICS AND THE KNEE WAS "QUIET", THE SECOND STAGE OF THE REV

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Loss of Range of Motion; Physical Asymmetry

  MAUDE report 19173443 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DATE OF RECEIPT OF COMPLAINT : 9 APRIL 2024. ON (B)(6) 2020 PATIENT UNDERWENT A FIRST STAGE OF LT TKR REVISION DUE TO "INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL JOINT PROSTHESIS (LEFT)" DURING WHICH HER IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. THEREAFTER PATIENT WAS PLACED IN PLASTER CAST/BRACE AND KNEE FIXATION AND RECEIVED A LONG TERM SYSTEMIC ANTIBIOTIC TREATMENT UNDER LABORATORY MONITORING. AFTER 6 WEEKS OF ANTIBIOTIC TREATMENT WITH VANCOMYCIN AND LABORATORY MONITORING FOR ADDITIONAL 2 MONTHS, IT WAS FOUND THAT THERE WAS NO INFLAMMATION OF THE INFECTION FOLLOWING CESSATION OF THE ANTIBIOTICS AND THE KNEE WAS "QUIET", THE SECOND STAGE OF THE REVISION WAS CARRIED OUT (B)(6) 2020 (NOTING IT WAS AFTER 9 PRIOR INFECTION REVISIONS). ON (B)(6) 2020 FOLLOW-UP VISIT - CRP LEVELS REDUCED TO 12 WITHOUT ANTIBIOTICS, IMAGING ¿ IMPLANT IN GOOD POSITION WITH RANGES OF FLEX AND BEND AS EXPECTED IN HER CONDITION. LESS THAN 2 YEARS AFTER IMPLANTATION PATIENT COMPLAINED OF HEAVY SENSATION ON THE LT LEG AND INSTABILITY OF LEFT KNEE. UPON EXAMINATION ON (B)(6) 2023 - OVER FLEXION OF 20 DEGREES AND LACK OF STABILITY ML. ON IMAGING: IMPRESSION OF LOOSENING OF THE TWO CO

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 19172954 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18005538 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELT A POP IN HIS RIGHT KNEE WHILE GOING DOWN SOME STAIRS. ON THE X-RAYS, IT APPEARED THE STEM BROKE AT THE JUNCTION BETWEEN THE STEM AND FEMORAL SLEEVE. THEY REMOVED AND REVISED. SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17573053 ↗
• InjuryMar 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD QUAD INSTABILITY, FELL AND DISLOCATED. DOI: UNKNOWN, DOR: ON (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Dislocation; Joint Laxity

  MAUDE report 16494543 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND STIFFNESS. PRIOR SURGERY WAS PERFORMED IN 2015. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO SURGICAL DELAY. DOI: 2015. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 15878312 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. THE FEMORAL COMPONENT AND INSERT WERE EXCHANGED. I&D WAS PERFORMED. THE LPS STEM, MBT TRAY, SLEEVE, AND STEM WERE LEFT IN SITU. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13930377 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHONE CALL WAS RECEIVED FROM A PATIENT TODAY. HE STATED THAT ON (B)(6) 2020, A PIECE BROKE WITHIN THE LPS AND A REVISION WAS DONE A COUPLE DAYS LATER. DOI: NOT INDICATED. DOR: NOT INDICATED. UNK KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Scar Tissue

  MAUDE report 12751110 ↗
• InjuryMay 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO FALL. DISLOCATED POLY FROM MBT TRAY AND LARGER POLY PUT IN. DOI: (B)(6) 2015; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 11841181 ↗
• 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 11796220 ↗
• InjuryOct 6, 2020Adverse 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 TOTAL KNEE. SURGEON REMOVED ONLY THE DISTAL FEMUR PARTS AND INSERT AND PERFORMED AN IRRIGATION AND DEBRIDEMENT AND REPLACED THE PARTS WITH THE SAME IMPLANTS THAT WERE REMOVED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10638586 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10546491 ↗
• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LPS DISTAL FEMORAL REPLACEMENT ON THE (B)(6) 2019. PATIENT WAS UNABLE TO ACHIEVE FULL EXTENSION, SO THE SURGEON DECIDED TO REVISE THE INSERT TO A THINNER SIZE. REVISED IMPLANT INFORMATION IS AS FOLLOWS: LPS TIBIAL INSERT HINGE UNIVERSAL 12MM REF: 1987-27-112, LOT: J27W26. IF OTHER, DESCRIBE : N/A, IF OTHER, DESCRIBE : REVISION KNEE - INSERT EXCHANGE., PATIENT STATUS/ OUTCOME / CONSEQUENCES : YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?: FIXED FLEXION DEFORMITY, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: : YES, IF YES, DESCRIBE : REVISION TO THINNER INSERT , OTHER INFORMATION : N/A, IS THE PATIENT PART OF A CLINICAL STUDY : UNKNOWN, (B)(4). DEVICE PROPERTY OF: PATIENT, DEVICE IN POSSESSION OF: ROYAL PERTH BIO-ENGINEERING BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.: TRUE.

  Patient problems: Joint Disorder; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10351103 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Pain

  MAUDE report 9855809 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2019, (B)(6) 2019 (INSERT ONLY). DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9749838 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9349898 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IRRIGATION AND DEBRIDEMENT WAS PERFORMED DUE TO INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8641237 ↗
• InjuryMay 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE TIBIAL INSERT DISLOCATED FROM THE TIBIAL TRAY.

  Patient problems: No Code Available

  MAUDE report 8619291 ↗
• InjuryMay 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DAMAGED ITEM: D1987-27-118. LOT: BFA0HNP. OPERATION DATE: (B)(6) 2019. DETAILS: THE POLY INSERT DISLOCATED. WHEN THE IMPLANT WAS REMOVED, IT HAD SEPARATED IN TO 2 COMPONENTS: THE INNER METAL AND THE OUTER PLASTIC.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8611842 ↗
• InjuryJan 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS POLY SWAP DUE TO INFECTION. DOI: (B)(6) 2017, DOR: (B)(6) 2017, LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7192939 ↗
• MalfunctionJan 3, 2018Disassembly; Disassembly

  IT WAS REPORTED THAT ON INVESTIGATION OF THE EXPLANT WE NOTICED THAT THE CENTRAL METAL PART OF THE PEG WITH HINGE RING HAD SEPARATED FROM THE REST OF THE INSERT.

  Patient problems: No Information

  MAUDE report 7161433 ↗
• InjuryJan 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DER STATES THAT THE PATIENT HAD PREVIOUS TK REVISION SURGERY ( NO OTHER INFORMATION ), PRESENTED TO SURGEON WITH INFECTION. SURGEON DID AN I & D WITH POLY EXCHANGE. USED A SMALL 18MM LPS HINGED INSERT. DOI: UNKNOWN; DOR: (B)(6) LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7156590 ↗
• InjuryDec 12, 2017Disassembly; Fracture; Disassembly; Fracture

  IT WAS REPORTED THAT HINGE INSERT WAS FOUND TO BE BROKEN/SEPARATED INTO TWO PARTS. THE METAL POST WAS DISLOCATED FROM THE POLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7109763 ↗