CONSERVE® 38AM4204Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M68438AM42041), received between Nov 10, 2020 and Jun 6, 2023 — classified as 4 injuries.

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

• InjuryJun 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, THE PATIENT UNDERWENT REVISION SURGERY, THE BROKEN FEMORAL STEM WAS IDENTIFIED, AND SOFT TISSUE WAS REMOVED AROUND THE FEMORAL HEAD AND IT WAS REMOVED, WE THEN REMOVED THE FEMORAL IMPLANT. WE IMPLANTED ANOTHER STEM. WE TOOK AN INTRAOPERATIVE X-RAY AND NOTED THERE WAS A PIECE OF THE DRILL BIT THAT MUST OF BROKEN DURING THE OSTEOTOMY PORTION OF THE CASE AND DISTAL ALONG THE STEM. WE THEN PLACED THE SIZE A/50 MM BODY WITH THE APPROPRIATE VERSION AND IMPACTED IT AND PLACED A LOCKING SCREW. WE THEN PLACED A 36/-6 BIOLOX HEAD AND IMPACTED. PRODUCTS NOT REVISED: PRODUCT ID: DSBFGG58, LOT: 05113366701551930, QTY: 1. PRODUCT ID: 18080303, LOT: 1543191, QTY: 1.

  Patient problems: Insufficient Information

  MAUDE report 17072916 ↗
• InjuryApr 13, 2021Positioning Problem; Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, THE PATIENT WAS REVISED DUE TO METAL ON METAL COMPLICATIONS ON ARTICULATING COBALT CHROME COMPONENTS. COMPONENTS NOT REVISED: PROFEMUR® Z FEMORAL STEM S 41/3 TP COATED CEMENT LESS / PRODUCT ID: PHA00266 / LOT NO.: 068599981. DYNASTY® PC SHELL 56MM GROUP F / PRODUCT ID: DSPCGF56 / LOT NO.: 107475199. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 4.0CM LENGTH / PRODUCT ID: 18080305 / LOT NO.: 078661945.

  Patient problems: Metal Related Pathology

  MAUDE report 11655415 ↗
• InjuryDec 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN, LACK OF MOBILITY AND HIGH LEVELS OF TOXIC METAL LEVELS. RIGHT HIP.

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

  MAUDE report 10936208 ↗
• InjuryNov 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY , PATIENT WAS REVISED DUE TO METALLOSIS AND COBALT TOXICITY. LEFT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 10816781 ↗