CONSERVE® 38AM4804Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M68438AM48041), received between Nov 15, 2019 and Mar 1, 2022 — classified as 7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT HAS A SCHEDULED REVISION SURGERY FOR (B)(6) 2022. NOT KNOWN REVISION CAUSES YET. ORIGINAL SURGERY INVOICE FOUND ON (B)(6),2022. ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2022 FROM REPORTER STATING: "THE SURGEON EXPLAINED TO ME THAT SHE IS KEEPING THE CUP AND STEM AND WILL BE CONVERTING IT TO A DUAL MOBILITY HEAD AND LINER AND WHILE IN THERE CHANGING THE TI NECK TO COBALT CHROME NECK." COMPONENTS THAT WILL NOT BE REVISED: 38HA4854 CONSERVE® PLUS HA CUP 48MM ID 54MM OD BEADED, LOT#: 067436643, QTY:1 PHA00262 PROFEMUR® Z FEMORAL STEM S 2 1/3 TP COATED CEMENT LESS, LOT#: 086363061, QTY:1

  Patient problems: Insufficient Information

  MAUDE report 13637172 ↗
• InjuryJan 21, 2021Mechanical Problem; Patient-Device Incompatibility

  ALLEGEDLY, PATIENT UNDERWENT A LEFT TOTAL HIP REPLACEMENT AND RECEIVED A MOM HIP SYSTEM IMPLANTS. PATIENT WAS REVISED DUE TO PAIN, LACK OF MOBILITY AND HIGH LEVELS OF TOXIC METAL LEVELS.

  Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 11207262 ↗
• InjuryJan 5, 2021Material Disintegration; Material Disintegration

  ALLEGEDLY, PATIENT WILL BE REVISED DUE TO ALLERGIC REACTION TO COBALT CHROMIUM METAL IONS AND PARTICULATE DEBRIS. ADDITIONAL INFORMATION RECEIVED ON 03/18/2020: MPO WAS INFORMED THAT THE REVISION SURGERY WAS CANCELED. ADDITIONAL INFORMATION RECEIVED ON 12/22/2020 FROM LEGAL DEPARTMENT ((B)(6)): ORIGINAL AND REVISION SURGERY DATES, REASON OF INCIDENT, PRODUCTS INVOLVED IN THE CASE. ALLEGEDLY, THE PATIENT UNDERWENT INTO REVISION SURGERY DUE TO METALLOSIS THROUGHOUT THE JOINT WITH BLACK STAINING TISSUE AND NECROTIC DEBRIS. BLACK CORROSIVE PRODUCT NOTED AT THE HEAD, NECK, AND NECK STEM MODULAR JUNCTIONS.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 11118728 ↗
• InjuryMay 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO METAL ON METAL COMPLICATIONS

  Patient problems: Reaction

  MAUDE report 10081135 ↗
• InjuryMar 11, 2020Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO METAL ON METAL COMPLICATIONS.

  Patient problems: Reaction

  MAUDE report 9821710 ↗
• InjuryMar 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY , PATIENT WAS REVISED DUE TO METAL ON METAL COMPLICATIONS.

  Patient problems: Reaction

  MAUDE report 9817861 ↗
• InjuryNov 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, REVISION DOCTOR STATED THAT PATIENT HAD ISSUES WITH METAL.

  Patient problems: Reaction

  MAUDE report 9328916 ↗