CONSERVE® 38AM5435Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M68438AM54351), received between Nov 15, 2019 and Mar 13, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ALLEGEDLY, REMOVED ORIGINAL HEAD AND NECK. REVISION DUE TO FEMORAL HEAD DISASSOCIATING FROM THE NECK TRUNION.

  Patient problems: Insufficient Information

  MAUDE report 21597932 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, REMOVED THE HEAD FOR SUSPECTED METALLOSIS AND PSEUDO-TUMOR. PRODUCTS NOT REVISED: PRODUCT: PROFEMUR LX STEM PRODUCT ID: PRLX0015, LOT#: 106380377; PRODUCT: PROFEMUR NECK 8DG VAR/NAL SHORT PRODUCT ID: PHA01252, LOT#: 086371800.

  Patient problems: Metal Related Pathology

  MAUDE report 14021216 ↗
• InjuryNov 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PAIN CUP NECK STAYED A DUAL MOBILITY LINER WAS USED W/OUR 28MM HEAD (RIGHT HIP). ELEVATED ION LEVELS AND METALLOSIS WERE REPORTED IN PROVIDED NOTES. THE CUP WAS NOT REVISED BUT CAPTURED AS A COMPLAINT DUE TO MOM ALLEGATIONS. OTHER ITEMS NOT REVISED: PROFEMUR RAZ STEM PYRD0008 LOT 036284376, PROFEMUR MODULAR NECK PHA01252 LOT 046335281.

  Patient problems: Reaction

  MAUDE report 9331092 ↗
• InjuryNov 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, MOM. HEAD WAS PULLED AND STRYKER DUAL MOBILITY LINER WAS USED WITH OUR METAL +7MM 28MM HEAD (LEFT HIP). THE CUP WAS NOT REVISED BUT CAPTURED AS A COMPLAINT DUE TO MOM ALLEGATIONS. OTHER ITEMS NOT REVISED: PROFEMUR RAZ STEM PYRD0008 LOT 036284376. PROFEMUR MODULAR NECK PHA01252 LOT 076363593.

  Patient problems: Reaction

  MAUDE report 9331079 ↗