Centrax 6226-2-653Recalls & reported problems
Howmedica Osteonics Corp. · Bipolar Duration Stabilized · Class 2 · Implant
All models of Centrax (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327032260), received between Mar 8, 2018 and Mar 27, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Packaging Compromised” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Device Packaging Compromised1
- Insufficient Device Problem Information1
Patient problems
- Injury1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
JOIN FOR BHA. RIGHT BHA WAS PERFORMED ON (B)(6) 2017. DUE TO INFECTION, HEAD WAS REMOVED ON (B)(6) 2018. CUP WAS REVISED ON (B)(6) 2018.
Patient problems: Injury; Unspecified Infection
MAUDE report 9888488 ↗MalfunctionMar 8, 2018Device Packaging Compromised; Device Packaging Compromised
IT WAS REPORTED THAT, DURING A BIPOLAR HIP ARTHROPLASTY, WHEN THE NURSE OPENED THE OUTER BLISTER PACK, OUR SALES REPRESENTATIVE FOUND A UNSEALED LID OF INNER BLISTER. THE CENTRAX WAS USED AS IS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7325176 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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