Morse Head 01-2810Recalls & reported problems
Howmedica Osteonics Corp. · Femoral Head · Class 2 · Implant
Data updated Oct 16, 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 07613327016154), received between Nov 4, 2020 and Nov 4, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K910988, K993601); 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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Ambulation or Postural Difficulties1
- Bone Fracture(s)1
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED: "RIGHT HIP REVISION DUE TO TRUNNION BREAK. ALL IMPLANTS LISTED BELOW (STEM, HEAD, LINER, AND SHELL) WERE EXPLANTED. NO MORE INFORMATION IS AVAILABLE PER DOCTOR." UPDATE: "SHELL REVISED TO CHANGE POSITION. NO ALLEGATIONS AGAINST LINER."
Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Failure of Implant
MAUDE report 10789180 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K910988, K993601. One submission often covers many models, so check the product and lot details in each record.
- Z-0390-2010 · Sep 4, 2009 · TerminatedStryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component.
- Z-0391-2010 · Sep 4, 2009 · TerminatedStryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.
- Z-1822-2009 · Jun 18, 2009 · TerminatedV 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp., Stryker Ireland, Carrigtwohill County Cork, Ireland; Intended f
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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