Centrax 6226-2-644Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327032178), received between Jan 9, 2018 and Feb 27, 2023 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT, 0002249697-2023-00192 WAS FOUND TO BE A DUPLICATE OF MFR REPORT # 0002249697-2019-01386. ALL DATA FOR THIS PATIENT'S EXPERIENCE WILL BE CAPTURED UNDER MFR REPORT # 0002249697-2019-01386. THIS PRODUCT INQUIRY IS BEING CLOSED AS A DUPLICATE. THE FOLLOWING HAS BEEN REPORTED: ADVERSE EVENT THAT OCCURRED IN JOIN STUDY CASE ((B)(4)). (B)(6), 2018: BHA PERFORMED. (B)(6), 2018: EARLY POSTOPERATIVE INFECTION WAS CONFIRMED. CLEANING AND REVISION OF INNER HEAD AND BIPOLAR CUP WAS PERFORMED. STEM PRESERVED. (B)(6), 2019: PATIENT'S OUTCOME WAS CONFIRMED AS "RECOVERY".

  Patient problems: Unspecified Infection

  MAUDE report 16442177 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT BECAME INFECTED POSTOPERATIVELY AND UNDERWENT LESION SCRAPING.

  Patient problems: Unspecified Infection

  MAUDE report 16402213 ↗
• InjuryAug 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS CASE WAS REPORTED BY THE CASE CARD OF THE STUDY JOIN. THE BHA WAS DONE WITH CENTRAX BIPOLAR CUP, V40 HEAD AND ACCOLADE 2 STEM AT (B)(6) 2016 FOR LEFT SIDE FEMORAL NECK FRACTURE. AT (B)(6) 2016 THE PATIENT HAD A LITTLE PAIN ON THE AFFECTED SIDE WHEN SHE WAS DISCHARGED FROM HOSPITAL. AND AT (B)(6) 2017 THE PATIENT DIED REGARDLESS OF THE BHA SURGERY.

  Patient problems: Pain

  MAUDE report 8889022 ↗
• MalfunctionJul 9, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT, DURING A BHA, A HEAD DID NOT SLIDE SMOOTHLY ON THE SLIDING SURFACE OF THE REPORTED CENTRAX. SPARE HEAD AND CENTRAX WERE USED INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773511 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE BHA WAS DONE WITH CENTRAX BIPOLAR CUP, V40 HEAD AND ACCOLADE 2 STEM AT 2018/11/21 FOR FEMORAL NECK FRACTURE. AT (B)(6) 2018, INFECTION WAS OCCURRED AND THE SURGEON CLEANED THE SURGICAL FIELD, EXCHANGED THE HEAD AND CUP. THE STEM WAS NOT CHANGED. AT 2019/JAN/17, THE PATIENT WAS RECOVERED. INFECTION WAS CONFIRMED CLINICALLY, MICROORGANISM UNKNOWN. PRE-EXISTING CONDITIONS: "STOMACH CANCER" RIGHT SIDE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8436277 ↗
• MalfunctionFeb 27, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A BHA; WHEN THE SURGEON COMBINED THE CENTRAX AND V40 HEAD, THE CENTRAX DID NOT SLIDE SMOOTHLY. A SPARE CENTRAX WAS USED INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7300562 ↗
• MalfunctionJan 9, 2018Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A BIPOLAR HIP ARTHROPLASTY, THE V40 HEAD DID NOT SLIDE SMOOTHLY ON THE INSERT OF THE CENTRAX.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7175788 ↗