Advantim 18080303Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684180803031), received between Jan 19, 2021 and Aug 30, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2022Migration; Migration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS COMPONENTS NOT REVISED: PRODUCT:PROFEMUR® L HIP STEM SIZE 5 HA COATED PRODUCT ID: PHA05510 LOT#:1674917 QTY:1 PRODUCT:PROFEMUR® NECK A/R 8DGLONG COBALT CHROME PRODUCT ID: PHAC1234 LOT#:1830376. QTY:1. REVISION NJR NUMBER: 4840985. SIDE:L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. ADDITIONAL INFORMATION ON 07/05/2022: POST OP X-RAY INDICATED THERE WAS POSSIBLY A NEED FOR REVISION. THE REVISION WAS CONDUCTED 8 (EIGHT) DAYS LATER. ACCORDING TO THE X-RAY THE PROCOTYL L WAS SPIN OUT, BUT THERE ARE NOT COPIES OF THIS X-RAY. WE RECEIVED TWO NEW PARTS WHICH BELONG TO SCREWS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15324945 ↗
• InjuryAug 16, 2022Corroded

  ALLEGEDLY, THE PATIENT ON (B)(6) 2020 HAD A LEFT REVISION SURGERY DUE TO CORROSION, ON (B)(6) 2020 THE PATIENT WAS REVISED AGAIN DUE TO INFECTION ON THE SIDE LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 15233387 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12908691 ↗
• InjuryMar 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, CUP, LINER, SCREW, HEAD EXTRACTED IN FAVOR OF A STRYKER REVISION CUP/CONSTRAINED LINER AND A MP 22 MM HEAD. ADDITIONAL INFORMATION WAS RECEIVED ON 03/17/2021 FROM DISTRIBUTOR: INCIDENT FORM CONTAINING SUBSTANTIAL INFORMATION, ALSO ON THIS DAY, REASON FOR REVISION. ALLEGEDLY, THE PATIENT HAD DISLOCATED SEVERAL TIMES.

  Patient problems: Insufficient Information

  MAUDE report 11589527 ↗
• InjuryJan 19, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, THE PATIENT WAS REVISED DUE TO CHRONIC KNEE PAIN, LOOSENING OF STEM AND COMPONENTS. (LEFT KNEE).

  Patient problems: Pain

  MAUDE report 11195964 ↗
• InjuryJan 19, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, THE PATIENT WAS REVISED DUE TO CHRONIC KNEE PAIN, LOOSENING OF STEM AND COMPONENTS. (LEFT KNEE).

  Patient problems: Pain

  MAUDE report 11195628 ↗