LPS 1987-10-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295078623), received between Dec 7, 2017 and Feb 5, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 21314283 ↗
• InjuryApr 10, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THE PATIENT WAS ASLEEP WHEN THE SALES REP ARRIVED IN THE OPERATING ROOM, RECHECKED THE MATERIAL AND REALIZED THAT THE PROXIMAL FEMORAL COMPONENTS WERE NOT DELIVERED (ONLY DISTAL COMPONENTS WERE PRESENT). THE MISSING DEVICE WERE NOT DELIVERED ON TIME BECAUSE OF THE UPDATE OF THE KIT ON THE SYSTEM. SURGICAL PROCEDURE RESCHEDULED FOR (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709414 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LPS PROXIMAL BODY AND 25MM SEGMENT. PATIENT ORIGINALLY HAD A FIRST STAGE REVISION (NOT WITH US) DUE TO INFECTION AND THE ON THE (B)(6) 2022 SHE HAD A 2ND STAGE REVISION USING OUR PROXIMAL LPS SYSTEM AS THE INFECTION MARKERS HAD GREATLY REDUCED. UNFORTUNATELY THE INFECTION HAS RETURNED AND THE PATIENT REQUIRED A SEVERE WASHOUT AND THEN A NEW PROXIMAL BODY AND 25MM SEGMENT WITH HEAD WAS REPLACEMENT WITH NEW IMPLANTS. RIGHT SIDE THR.

  Patient problems: Unspecified Infection

  MAUDE report 15300333 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF PFR AND BIPOLAR HEAD DUE TO INFECTION. WASHED OUT AND REIMPLANTED NEW COMPONENTS. NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15249302 ↗
• InjurySep 22, 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 INFECTION. THE PATIENT WENT THROUGH SEVERAL I&DS AND WOULD NOT GET BETTER. THE SURGEON DECIDED TO DO A HIP DISARTICULATION. THE STEM, LINER AND CUP HAD TO COME OUT. THERE WERE NO INSTRUMENTS BROKEN OR DAMAGED. ALL COMPONENTS WERE REMOVED. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (LEFT HIP).

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

  MAUDE report 12517275 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO OR DUE TO NON-HEALING WOUNDS POST-TREATMENT FOR RECURRENT INFECTION. MODULAR COMPONENTS WERE EXCHANGED, ANTIBIOTIC AND ANTIFUNGAL BEADS WERE PLACED. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 12354198 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO FRACTURE OCCURRED. A CABLE WAS UTILIZED DURING BONY PREPARATION TO PREVENT FRACTURE. AN INFECTION WAS CONFIRMED VIA CULTURES ROUGHLY 72HRS AFTER SURGERY, AT WHICH POINT I AM NO LONGER PRESENT. IT IS THE SURGEONS BELIEF THAT IT WAS LIKELY INFECTED AND THUS CHOOSE TO EXCHANGE COMPONENTS. ANOTHER ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROSTALAC CUP WAS USED AS A PRIMARY CUP FOR THIS PATIENT. THERE WERE NO IMPLANTS IN MS HALL ON (B)(6) 2020. IF I REMEMBER CORRECTLY, SHE HAD A CEPHALOMEDULLARY NAIL REMOVED FOR INFECTION AT ANOTHER INSTITUTION PRIOR TO SEEKING CARE FROM THIS SURGEON.

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

  MAUDE report 11195339 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO OPERATING ROOM FOR REMOVAL OF HARDWARE DUE TO INFECTION AND ONE STAGE REVISION WAS PERFORMED WITH PLACEMENT OF ANTIBIOTIC BEADS. DOI: (B)(6) 2014; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9186621 ↗
• InjuryJun 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES CHRONICALLY INFECTED AND RECURRENTLY DISLOCATED LPS PROXIMAL FEMUR TOTAL HIP. IRRIGATION AND DEBRIDEMENT WITH EXCHANGE OF COMPONENTS AND CONVERSION TO A CONSTRAINED LINER. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7641644 ↗
• InjuryJun 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT HAS A DISLOCATED AND INFECTED TOTAL HIP WITH DRAINING SINUS. IRRIGATION AND DEBRIDEMENT WAS PERFORMED. SURGEON DECIDED TO REMOVE WELL FIXED CEMENTED LPS STEM AND RESECT ADDITIONAL PROXIMAL FEMUR.  DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP. DOI STEM: (B)(6) 2015.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7586339 ↗
• InjuryMay 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTED TOTAL HIP WITH DRAINING SINUS TRACT. IRRIGATION AND DEBRIDEMENT WITH EXCHANGE OF COMPONENTS. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7536913 ↗
• InjuryDec 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTED LEFT HIP WITH DRAINING SINUS TRACT. IRRIGATION AND DEBRIDEMENT AND EXCHANGE OF COMPONENTS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 7095312 ↗