LPS 1987-25-109Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295079132), received between Jul 2, 2019 and Sep 1, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to fracture.DOI: UnknownDOR: (b)(6), 2026Affected side: Left Knee.

  Patient problems: Bone Fracture(s)

  MAUDE report 50544114 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUES TO BE INFECTED. THE SPACER AND ALL CEMENT ARE REMOVED. A THOROUGH I&D IS PERFORMED AND A NEW SPACER IS FASHIONED UTILIZING LPS COMPONENTS. NO PATIENT HARM NOR DELAY WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23477322 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO DRAIN AFTER HER PROCEDURE. LABS LOOK GOOD AND ASPIRATION IS NEGATIVE FOR INFECTION. SURGEON BELIEVES THE ANTIBIOTICS PLACED A THE TIME OF SURGERY ARE CAUSING THE DRAINAGE, SO HE CHOSE TO REMOVE ALL COMPONENTS AND PLACE NEW ONES. NO DELAY NOR PATIENT HARM IS NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THEY WERE FUNCTIONING AS EXPECTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 22441068 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS INFECTION AND ALL COMPONENTS WERE REMOVED AND A SPACER WAS MADE WITH NEW COMPONENTS. HIGH DOSE ANTIBIOTICS WERE PLACED ON COMPONENTS ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. HICKMAN CATHETERS WERE ALSO PLACED TO PROVIDE ADDITION ANTIBIOTIC TREATMENT POSTOPERATIVELY. NO PATIENT HARM WAS NOTED AND NO DELAY OCCURRED. INITIAL PROCEDURE FEMORAL SIDE COMPONENTS WERE REVISED ON (B)(6) 2024. AN I&D WITH FEMUR AND INSERT EXCHANGE WAS PERFORMED ON (B)(6) 2025 AND (B)(4) WAS SUBMITTED. THERE WAS A LOOSENING REPORTED AT STEM ON BONE TO CEMENT INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22373078 ↗
• InjuryJun 25, 2025Fracture; Noise, Audible; Fracture; Noise, Audible

  IT WAS REPORTED THIS PATIENT HAD A LPS DISTAL FEMORAL REPLACEMENT IN FEBRUARY. DR PLACED A 9MM CEMENTED LPS STEM IN THE FEMUR. PATIENT DID WELL UNTIL HE HEARD A SNAP. THE STEM BROKE AT THE BASE. SURGEON REVISED THIS TO A TOTAL FEMUR. LINKING THE NEW PROXIMAL FEMUR AND SEGMENTS TO THE EXISTING DISTAL FEMUR AND SEGMENTS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22330191 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUED TO DRAIN FROM KNEE WOUND. SURGEON ELECTED TO REMOVE KNEE PROSTHESIS AND FUSE THE KNEE. THIS COMPLAINT (B)(4) IS RELATED TO (B)(4). DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22329278 ↗
• InjuryMar 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH A PAINFUL RIGHT KNEE. PATIENT HAD A REVISION OF A RIGHT DISTAL FEMUR. IT WAS DETERMINED PER X-RAY THAT THE LPS CEMENTED STEM 9MM X 100MM STRAIGHT STEM HAD BROKEN. DOCTOR REMOVED THE IMPLANTS AND REVISED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21545751 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUES TO HAVE RECURRENT INFECTIONS AND INFLAMMATION AROUND PATIENT'S PROSTHESIS EVEN AFTER MULTIPLE 2 STAGE REVISIONS. THE QUESTION HAS BEEN RAISED AS TO WHETHER PATIENT IS HAVING A REACTION TO THE METAL. THEREFORE, ALLERGY TESTING IS GETTING DONE FOR PATIENT BUT FOR THAT PATIENT NEEDS TO KNOW THE EXACT COMPOSITION OF IMPLANTS SO DERMATOLOGY KNOW WHAT TO TEST FOR.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 21314298 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT RECEIVED A KNEE ENDOPROSTHESIS (PARTIALLY COUPLED SYSTEM) FOR LEFT KNEE IN (B)(6) 2015, THE TIBIAL COMPONENT AND THE INLAY WERE CHANGED TO INCREASE THE TENSION. ON (B)(6) 2021, THE PATIENT SUDDENLY EXPERIENCED PAIN IN THE LEFT KNEE WITHOUT ANY EXTERNAL INFLUENCE, WHICH IS WHY SHE VISITED THE HOSPITAL. AFTER A CT EXAMINATION, A DISLOCATED PERIPROSTHETIC FRACTURE WAS DETECTED MEDIALLY AT THE DISTAL FEMUR ON (B)(6) 2021, AS WELL AS A COLLAPSE OF THE FEMORAL PROSTHESIS AT THE LEVEL OF THE FRACTURE. IN THE YEARS 2015 TO 2020 THERE ARE ANNUALLY FINDINGS CONFIRMING THAT THERE HAVE NEVER BEEN ANY SIGNS OF LOOSENING OF THE PROSTHESIS.

  Patient problems: Joint Laxity; Limb Fracture; Pain

  MAUDE report 20450382 ↗
• InjuryJan 19, 2024Fracture; Fracture

  PATIENT WAS REVISED DUE TO THE DISTAL STEM 9MMX100 CEMENTED STEM ARE BROKE IN HALF. DOI- (B)(6) 2023. DOR- (B)(6) 2024. AFFECTED SIDE- UNK KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18541765 ↗
• InjuryFeb 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE 9 X 100 MM CEMENTED LPS STEM BROKE. SUPPOSEDLY, THIS IS THE SECOND TIME THIS HAS HAPPENED TO THIS SPECIFIC PATIENT. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16276760 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEVERE RHEUMATOID ARTHRITIS AND DEVELOPED A SIGNIFICANT FLEXION CONTRACTURE. THE SURGEON'S BELIEF WAS THE EASIEST WAY TO ADDRESS WAS TO SHORTEN THE FEMORAL SIDE. THE FEMORAL COMPONENT WAS REMOVED, THE FEMUR RESECTED UNTIL THE KNEE WOULD STRAIGHTEN AND NEW COMPONENTS WERE PLACED WITH NO COMPLICATIONS OR HARM. NO SURGICAL DELAY. DOI: (B)(6) 2014, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 14955950 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. IMPLANTS WERE TAKEN OUT. PRESS FIT COMPONENTS IMPLANTED. NO INSTRUMENTS BROKEN. NO POST OP AND XRAYS AVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9180306 ↗
• InjuryJul 2, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE 9X100MM CEMENTED STEM FRACTURED JUST PAST CEMENT MANTLE. REPLACED WITH LARGER DIAMETER STEM. DOI: (B)(6) 2018. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8753573 ↗