LPS 1987-07-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295078593), received between Nov 13, 2018 and Jan 9, 2026 — classified as 6 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 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.

• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD MULTIPLE PRIOR REVISIONS. THIS WAS DONE FOR DISLOCATION LINER WAS CHANGED TO A CONSTRAINED LINER. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24024144 ↗
• 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 15397675 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. CEMENT IS HOSPITAL INVENTORY SO NO PART, LOT OR QUANTITY IS AVAILABLE IN MY RECORDS. SURGEON ROUTINELY USES DEPUY 2 WITH GENT IN HIS REVISION PROCEDURES. B. 10-16-2020. C. LOOSENING IS UNEXPLAINED. THE SURGEON SUSPECTED INFECTION BUT CULTURES WERE NOT POSITIVE FOR INFECTION.

  Patient problems: Blister; Unspecified Infection

  MAUDE report 12712235 ↗
• 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 10830212 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HETEROTOPIC OSSIFICATION. A THOROUGH I&D WAS PERFORMED WITH REMOVAL OF HETEROTOPIC OSSIFICATION AND PLACEMENT OF ANTIBIOTIC CEMENT AND BEADS. THE PATIENT IS STILL DRAINING. MODULAR COMPONENTS WERE EXCHANGED, STEMS WERE WELL FIXED AND WERE LEFT IN PLACE. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Extraskeletal ossification; Fluid Discharge; No Code Available; Unspecified Infection

  MAUDE report 10049233 ↗
• InjuryNov 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8063778 ↗