LPS 1987-27-216Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295079507), received between Dec 15, 2017 and Jul 12, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A DRAINAGE FROM INCISION SITE. THE PATIENT ALSO HAD IRRIGATION AND DEBRIDEMENT (I&D) WITH POLY SWAP. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 19730670 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIRST SURGERY WAS ON THE (B)(6) 2022, AFTER STERILIZING THE MATERIAL REMOVING THE INNER BOXES, THE TRAYS AND PUTTING EVERYTHING WRAPPED IN PAPER AND ALL THE STERILE MATERIAL CAME OUT, BUT TODAY DR. (B)(6) (THE SURGEON), HAS RETURNED TO THE PATIENT, BECAUSE THE WOUND STAINED AND THEY SUSPECT THAT IT IS INFECTED, FOR THAT REASON THEY HAVE PUT IT TODAY TO OPEN THE WOUND AND WASH IT ABUNDANTLY TO SEE IF YOU CAN AVOID HAVING TO REMOVE ALL THE MATERIAL. AS I TOLD YOU, THE SURGERY OF DAY 7TH, WAS A REPLACEMENT OF A PTR THAT HAD EATEN POLYETHYLENE AND WAS TOUCHING METAL / METAL, WHICH HAD CAUSED AN ENORMOUS METALLOSIS IN THE JOINT, DURING THE SURGERY THE KNEE PROSTHESIS THAT HAD THE PATIENT WAS REMOVED, METALLOSIS WAS REMOVED AND OUR NOILES KNEE REPLACEMENT PROSTHESIS WAS IMPLANTED. AT THAT TIME THERE WERE NO MARKERS OF ANY POSSIBLE INFECTION. TODAY, AFTER TAKING SAMPLES, WASHING THE WOUND AND CLEANING IT, WE PROCEEDED TO CHANGE THE POLYETHYLENE AND THE PIN, THE REST OF THE COMPONENTS WERE MAINTAINED. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN. DID THE P

  Patient problems: Unspecified Infection

  MAUDE report 16131834 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD HER RIGHT KNEE REVISED ON 4/19/18 WHERE HER SIGMA TC3 CONSTRUCT WAS CONVERTED TO A HINGE KNEE CONSTRUCT BECAUSE OF INSTABILITY. THIS PATIENT RECENTLY BEGAN TO EXPERIENCE PAIN AND COMFORT IN HER KNEE AND IT WAS DETERMINED THAT THE JOINT HAD AN INFECTION PRESENT. THE DOCTOR BROUGHT THE PATIENT IN FOR A THOROUGH I & D. THE LPS INSERT WAS EXPLANTED AND REPLACED WITH A NEW INSERT. ALL OF THE OTHER COMPONENTS WERE LEFT. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 14381766 ↗
• InjuryOct 8, 2021Adverse 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 LEFT TOTAL KNEE THAT WAS REVISED APPROXIMATELY 10 YEARS AGO. SURGEON PERFORMED AN IRRIGATION AND DEBRIEDMENT AND REPLACED THE INSERT, HINGE PIN, AND BUMPER. DOI: 10 YEARS AGO, DOR: (B)(6) 2021, (LEFT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 12599010 ↗
• InjuryNov 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND POLY EXCHANGED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 8101344 ↗
• InjuryDec 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7120814 ↗