28mm Femoral Head, 12/14 taper, +3.5mm offset 3200.28.350Recalls & reported problems
Total Joint Orthopedics, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814703012181), received between Oct 26, 2020 and Oct 26, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Compatibility Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K143113); they may or may not involve this specific model.
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
- Compatibility Problem1
Patient problems
- Pain1
- Toxicity1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 26, 2020Compatibility Problem; Compatibility Problem
PATIENT HAD PAIN STARTING 6 MONTHS AGO. ORIGINALLY DIAGNOSED AS PSOAS IMPINGEMENT AND GAVE PATIENT AN INJECTION. INJECTION DIDN'T HELP SO LABS WERE DONE. LABS SHOWED NO INFECTION AND SLIGHTLY ELEVATED COBALT CHROMIUM LEVELS AT 7. WENT TO 12 LAT MONTH AND COBALT CHROMIUM LEVELS HAD ALMOST DOUBLED IN A FEW MONTHS. CT AND MRI WERE PRETTY NORMAL. REVISION SURGERY WAS DONE. FEMORAL STEM SHOWED DAMAGE BELOW THE TAPER.
Patient problems: Pain; Toxicity
MAUDE report 10733739 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K143113. One submission often covers many models, so check the product and lot details in each record.
- Z-0432-2026 · Sep 23, 2025 · Open, ClassifiedBrand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.4
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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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