LPS 1987-27-116Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295079415), received between Jul 27, 2017 and Jan 12, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  METALLOSIS CAUSED BY THE JUNCTION OF THE DFR IMPLANTS. MORE SPECIFICALLY, THE FEMORAL COMPONENT (MADE OF COBALT CHROME) AND THE SEGMENT (MADE OF TITANIUM), WHICH SEEMED TO HAVE CAUSED LYSIS AND INFECTION OVER TIME BECAUSE OF THE NEGATIVE IMPLANT WEAR. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction; Osteolysis; Unspecified Infection

  MAUDE report 24040327 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR KNEE REVISION ¿ PAIN/STIFFNESS. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: (B)(6) 2025, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 22653052 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTS IN ER WITH WHAT IS BELIEVED TO BE AN ACUTE INFECTION AND A RUPTURED PATELLA TENDON. SURGEON PERFORMS A THOROUGH I&D WITH COMPONENT EXCHANGE OF MODULAR COMPONENTS. ALL COMPONENTS WERE WELL FIXED AND ALIGNED. RESORBABLE ANTIBIOTIC BEADS ARE PLACED AND TENDON IS REATTACHED/ REPAIRED VIA SUTURE. NO PATIENT HARM NOR DELAY WERE NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS ALL WERE PERFORMING NORMALLY UNTIL THIS POINT. LOT INFORMATION IS NOT AVAILABLE AS THIS WAS NOT TRANSFERRED DURING THE MIGRATION FROM COMPASS TO OPTIMIZE. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22566147 ↗
• InjurySep 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED HINGE BEARING FROM TIBIA, SURGEON REVISED FEMUR TO FIX ROTATION. HE REUSED THE X SMALL LEFT DFR AND 25 MM SEGMENT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 20148061 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INFECTED KNEE. NO SURGICAL DELAY. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 18958056 ↗
• InjuryFeb 8, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  PLEASE CLARIFY IF THE TIBIAL INSERT AND TRAY CAME APART OR DID THE TIBIAL INSERT FRACTURE. THE INSERT FRACTURED.

  Patient problems: Joint Dislocation

  MAUDE report 18667175 ↗
• InjuryApr 11, 2023Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT EXPERIENCED PAIN AND INSTABILITY. A SURGICAL TIME EXTENSION OF APPROXIMATELY 30 MINUTES ALSO OCCURRED DUE TO THE PRONOUNCED PERIARTICULAR CALCIFICATIONS.

  Patient problems: Calcium Deposits/Calcification; Joint Laxity; Pain

  MAUDE report 16712061 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION LPS FOR PATELLA SCARRING/CLUNKING AND PAIN - APPEARED TO BE TISSUE RUBBING ON POROUS COLLAR ON LPS STEM. LPS REMOVED AND LPS WITH SLEEVE PUT IN. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Pain; Scar Tissue

  MAUDE report 12513000 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. A WASHOUT WAS DONE, AND THE POLY & PIN WERE REMOVED AND REPLACED WITH NEW ONES. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11974287 ↗
• InjurySep 3, 2020Fracture; Fracture

  A PATIENT WHO UNDERWENT REVISION KNEE SURGERY BEFORE 6 YEARS WITH THE PROSTHESIS MBT TIBIA AND SROM NOILS FEMUR, THE INSERT'S ROD THAT SET INTO TIBIA POCKET WAS BROKEN AND LEAD TO DISLOCATION OF THE KNEE

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10489205 ↗
• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESSED INFECTION. INCISION AND DRAINAGE WAS DONE WITH POLY EXCHANGED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10367873 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D POLY EXCHANGE WAS DONE. ASPIRATION OF PUSS. NO CULTURE RESULTS YET. DOI: (B)(6) 2019 DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9209307 ↗
• InjurySep 26, 2019Adverse 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) 2017. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9122994 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SEVERE PATELLA CREPITUS. SURGEON REMOVED ALL TISSUE AROUND PATELLA. ALSO EXCHANGED ZIMMER PATELLA THAT WAS IMPLANTED FROM INDEX PROCEDURE TO A SIGMA PATELLA. SURGEON NOTED SOME LAXITY ALSO CHANGED TO A 2 MM THICKER INSERT. DOI: (B)(6) 2019. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9088262 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED LEFT KNEE. LPS POLY INSERT WAS EXCHANGED. WASH OUT AND I&D WERE PERFORMED. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8842888 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. POLY EXCHANGE WAS DONE. DOI: UNK; DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8374398 ↗
• InjuryOct 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT RECEIVED A LEFT DISTAL FEMUR REPLACEMENT IN 2011 OR 2012 AT (B)(6) HOSPITAL. PATIENT WAS REFERRED TO SURGEON FOR LEFT KNEE PAIN, THE SURGEON CLEANED OUT KNEE JOINT/ TOOK CULTURES AND REPLACED THE DISTAL FEMUR COMPONENT / HINGE PIN AND 16 MM X-SMALL INSERT AND ANTIBIOTIC BEADS.

  Patient problems: Pain

  MAUDE report 6937880 ↗
• InjuryJul 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE.

  Patient problems: Pain

  MAUDE report 6746827 ↗