LPS 1987-12-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295078661), received between Nov 12, 2020 and Dec 4, 2024 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH HIP PAIN AND INABILITY TO BEAR WEIGHT. XRAYS SHOWED THAT THE ACETABULAR SHELL WAS NO LONGER IN PLACE AND IS THROUGH THE MEDIAL WALL. THERE WAS NON-CEMENTED LOOSENING OF THE ACETABULAR SHELL. THE PATIENT WAS ADMITTED AND SCHEDULED FOR SURGERY TO REMOVE EXISTING COMPONENTS. NO DELAY OR HARM WAS NOTED. THE PROXIMAL FEMORAL COMPONENT TO INCLUDE THE HEAD AND DM POLY LINER WERE REMOVED. ACETABULAR COMPONENT WAS ALSO REMOVED WITH NO COMPLICATION. DUE TO LACK OF BONE STOCK, NO COMPONENTS WERE REPLACED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 20845715 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD FAILED CONSTRAINED LINER FROM A CONSTRAINED LINER FROM ANOTHER MANUFACTURER. THE SURGEON CHOSE TO CHANGE VERSION TO REDUCE IMPINGEMENT. THERE WAS NO DELAY OR PATIENT HARM. DOI: (B)(6) 2016 . DOR: (B)(6) 2024 . AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 19141828 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT COMES INTO ER AND WITH PAIN AND NOT FEELING WELL. XRAYS SHOW HETEROTOPIC BONE FORMATION AND WHAT APPEARS TO BE GAS IN TISSUES SURROUNDING THE IMPLANT, SIGNIFYING INFECTION. ONCE OPENED, GROSS PUS WAS NOTED CONFIRMING INFECTION. A THOROUGH I&D WITH REMOVAL OF HETEROTOPIC BONE, EXCHANGE OF COMPONENTS, PLACEMENT OF ANTIBIOTIC BEADS AND COATING OF PROSTHESES WITH HIGH DOSE ANTIBIOTIC CEMENT IS PERFORMED. CEMENT WAS LIKELY GMV WITH GENT BUT WOULD HAVE BEEN HOSPITAL OWNED SO NO LOT INFO OR CONFIRMATION IS AVAILABLE IN MY RECORDS. NO PATIENT HARM OCCURRED. THIS PATIENT DOES HAVE MULTIPLE SIGNIFICANT COMORBIDITIES WHICH MAKE HER MORE PRONE TO INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Extraskeletal ossification; Pain; Unspecified Infection

  MAUDE report 16195661 ↗
• InjurySep 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO SURGERIES TOOK PLACE PRIOR TO THIS CASE UTILIZING JNJ IMPLANTS, (B)(6) 2020 WITH THE FIRST SURGEON AT THE HOSPITAL, AND THEN AT ANOTHER HOSPITAL WITH THE ANOTHER SURGEON ON (B)(6) 2021. THE INITIAL CASE WITH THE FIRST SURGEON WAS A TOTAL FEMUR FOR TREATMENT OF CHRONIC INFECTION. THE OTHER SURGEON THEN CONVERTED THE TOTAL FEMUR TO A KNEE FUSION AS HER QUAD MECHANISM FAILED. ULTIMATELY THE PATIENT HAD A HIP DISARTICULATION ON (B)(6) 2022 AS THE INFECTION RESURFACED. A DER WAS SUBMITTED WHEN THE SECOND SURGEON PERFORMED HIS PROCEDURE. NO PT HARM WAS CREATED BY JNJ IMPLANTS. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15397672 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD WOUND DEHISCENCE. THE SURGEON PERFORMED A THOROUGH I&D WITH COMPONENT EXCHANGE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 10830226 ↗