CONSERVE® 38AM4800Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M68438AM48001), received between Dec 18, 2019 and Jun 1, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.

• InjuryJun 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT IS EXPERIENCING MOM COMPLICATIONS (RIGHT). THE PATIENT HAS SCHEDULED TO HAVE THE RIGHT HIP IMPLANT EXPLANTED IN (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED ON 05/11/2023: ALLEGEDLY, DUE TO WE RECEIVED A NEW INFORMATION ABOUT A REVISION SURGERY PERFORMED ON 2023, WE FOUND AN INVOICE OF THE REVISION SURGERY PERFORMED ON 2014, A CONSERVE A-CLASS BFH HEAD MEDIUM NECK 40MM (38AM4000) AND PROFEMUR NECK NEUTRAL LONG COBALT CHROME (PHAC1204) WERE IMPLANTED, THIS MEANS THE HEAD AND NECK IMPLANTED IN THE PRIMARY SURGERY WERE REVISED. THE CUP (PRODUCT ID: 38024854 CONSERVE® PLUS CUP, LOT: 108676882, QTY: 1) IS UNSURE THAT WAS REVISED.

  Patient problems: Metal Related Pathology

  MAUDE report 17039021 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, IN THE REVISION SURGERY THE DR NOTED THAT THERE WAS A LARGE SOFT TISSUE MASS (PSEUDOTUMOR) IN THE POSTERIOR ASPECT OF THE HIP CAPSULE AND EXTERNAL ROTATORS ADDITIONAL THAT THERE WAS A SIGNIFICANT AMOUNT OF METAL-STAINED TISSUE INVOLVING SYNOVIUM, CAPSULE AND BONE IN BOTH, FEMUR AND ACETABULUM, THAT HE REMOVED AN EXCESSIVE AMOUNT OF MEMBRANES, METALLOSIS AND OSTEOLYTIC SOFT TISSUE. BECAUSE THE HIP STEM WAS WELL FIXED, AN EXTENDED TROCHANTERIC OSTEOTOMY WAS REQUIRED TO REMOVE THE PROFEMUR® PLASMA Z STEM IN PLAINTIFF'S LEFT HIP AND REMOVED ALL OF THE WRIGHT MEDICAL DEVICES THAT HAD BEEN IMPLANTED IN PLAINTIFF'S LEFT HIP, EXCEPT FOR THE CONSERVE® PLUS SPIKED CUP, WHICH WAS WELL FIXED AND LEFT IN PLACE. IN (B)(6) 2021 PLAINTIFF DEVELOPED ADVERSE SYMPTOMS INCLUDING, BUT NOT LIMITED TO, PROGRESSIVELY WORSENING PAIN IN AND AROUND HIS HIP JOINTS. IN (B)(6) 2021 AN MRI DEMONSTRATED LARGE FLUID FILLED COLLECTIONS OVER BOTH OF PLAINTIFF'S HIPS. IN (B)(6) 2021 LABORATORY TESTS ALSO REVEALED THAT PLAINTIFFS COBALT AND CHROMIUM LEVELS IN HIS BLOOD WERE SIGNIFICANTLY ELEVATED.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 14375128 ↗
• InjuryMar 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO RIGHT HIP ADVERSE LOCAL TISSUE REACTION.

  Patient problems: Reaction

  MAUDE report 9786853 ↗
• InjuryDec 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, POSSIBLE INFECTION/MOM. PATIENT HAD WHAT APPEARED TO BE A SORE OR WOUND ON THEIR HIP PRE SURGERY, CULTURES WERE TAKEN AND THE HEAD WAS PULLED AND A NEW 28MM LONG CERAMIC WAS USED WITH A STRYKER DUAL MOBILITY. THE PATIENT HAS UNDERGONE PREVIOUS REVISIONS DUE TO DISLOCATION, INFECTION ON (B)(6) 2010, (B)(6) 2010 AND (B)(6) 2010 (ALL COMPONENTS REVISED). RIGHT HIP.

  Patient problems: Reaction; Unspecified Infection

  MAUDE report 9491715 ↗