ABG 4845-0205Recalls & reported problems
Howmedica Osteonics Corp. · Femoral Stem - Left · Class 2 · Implant
All models of ABG (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327051032), received between Nov 23, 2020 and Mar 30, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Corroded1
- Device Dislodged or Dislocated1
- Malposition of Device1
Patient problems
- Ambulation or Postural Difficulties2
- Fall1
- Foreign Body Reaction1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2025Corroded; Device Dislodged or Dislocated; Corroded; Device Dislodged or Dislocated
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP AND WAS REVISED ON (B)(6) 2024. IT IS FURTHER ALLEGED THAT THE TAPER HAD COMPLETELY CORRODED AND THE FEMORAL HEAD HAD FALLEN OFF INTO THE ACETABULUM.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 21728707 ↗InjuryOct 4, 2021Fracture; Fracture
IT HAS BEEN REPORTED THAT: "(B)(6) PATIENT WITH A LEFT TOTAL HIP PROSTHESIS IN 2008. RUPTURE OF THE LEFT TOTAL HIP PROSTHESIS AT THE NECK OF THE STEM, FOLLOWING AN IMPACT WITH A DOOR AND A FALL WITH LANDING ON THE LEFT HIP. PAIN IN THE LEFT HIP WITH FUNCTIONAL IMPOTENCE MIG. ACTION TAKEN: ORTHOPAEDIC SURGERY TO FIT NEW PROSTHETIC MATERIAL."
Patient problems: Fall; Pain
MAUDE report 12569339 ↗InjuryJun 24, 2021Malposition of Device; Malposition of Device
AS REPORTED IN MEDWATCH MW5101277: "I AM THE PATIENT RELATED TO THE FDA REPORT: STRYKER ORTHOPAEDICS-(B)(4) ABG II NO. 5 CEMENTLESS LEFT V40 CATALOG NUMBER 4845-0205 EVENT DATE (B)(6) 2013 MDR REPORT KEY (B)(4). THIS IS THE PROSTHESIS THAT WAS PUT ON ME: STRYKER ORTHOPEDICS-(B)(4) ABG II NO 5 CEMENTLESS LEFT V40. AFTERWARDS, TWO CT SCANS, ONE PERFORMED ON (B)(6) 2013 AND THE OTHER - RESOLUTIVE - ON (B)(6) 2013, SHOWED THAT THE PROSTHESIS WAS BADLY POSITIONED AND FOR THIS REASON AN IMPINGEMENT HAD BEEN CAUSED BETWEEN THE STEM AND THE ACETABULAR CUP (INCLUDING POLYETHYLENE INSERT). THE ACETABULAR CUP HAD BEEN IMPLANTED WITH POOR ANTEVERSION: THE ANTEVERSION ANGLE OF 20° WAS NOT RESPECTED AND IT WAS ONLY 7°. THIS FACT HAD INJURED THE ILIOPSOAS TENDON, WHICH HAS NEVER RECOVERED, EVEN AFTER THE REMOVAL AND REPLACEMENT OF THE PROSTHESIS. THE TESTS TO WHICH STRYKER REFERS IN THE REPORT OF THE CASE, WERE ONLY NICKEL AND CHROMIUM BECAUSE STRYKER ON (B)(6) 2013 HAD NOT YET PROVIDED THE DOCTOR WHO HAD MADE THE REPORT, THE TECHNICAL DATA SHEET OF THE PROSTHESIS, WHERE ALL THE METALS TO BE SEARCHED WERE INDICATED. ACTUALLY, I HAVE THE EMAIL IN WHICH STRYKER CONFIRMS THE OPENING OF THE ACCIDENT
Patient problems: Foreign Body Reaction
MAUDE report 12061525 ↗InjuryNov 23, 2020Fracture; Fracture
DR. REPORT: "I WOULD LIKE TO INFORM YOU OF THE WEAR (BREAKAGE) OF THE FEMORAL STEM NECK OF THE ABG PROSTHESIS. CODE: HOW / OST 4845-0205 ABG II FEMORAL STEM LEFT. THE PATIENT HAD TO UNDERGO A PROSTHETIC REPLACEMENT SURGERY - ON (B)(6) 2020"
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 10883613 ↗
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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