ABGRecalls & reported problems across all models
Howmedica Osteonics Corp. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 0
We found 10 models of ABG by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2018 and Mar 24, 2026 — classified as 25 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ABG problems
Device problems
- Fracture11
- Detachment of Device or Device Component4
- Insufficient Device Problem Information4
- Corroded3
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Degraded2
- Device Dislodged or Dislocated2
Patient problems
- Ambulation or Postural Difficulties7
- Injury7
- Insufficient Information6
- Pain5
- Metal Related Pathology4
- Bone Fracture(s)2
- Fall2
- Inadequate Osseointegration2
ABG models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ABG 4845-0106PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- ABG 4845-0205Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented4 reports
- ABG 4845-0207Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate4 reports
- ABG 4845-0107Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- ABG 4845-0105Prosthesis, hip, semi-constrained, metal/polymer, uncemented2 reports
- ABG 4845-0104Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- ABG 4845-0102Prosthesis, hip, hemi-, femoral, metal2 reports
- ABG 4845-0204Prosthesis, hip, semi-constrained, metal/polymer, uncemented2 reports
- ABG 4845-0103Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ABG 4845-0208Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
Recent ABG adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 24, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: FRACTURE OF THE FEMORAL STEM NECK.
Patient problems: Insufficient Information
MAUDE report 24681752 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT REPORTED THAT HE ALLEGEDLY UNDERWENT RIGHT HIP REPLACEMENT SURGERY ON (B)(6) 2011, AND IN (B)(6) 2025 HE BEGAN EXPERIENCING CLICKING SOUNDS IN HIS RIGHT HIP. BLOOD TESTS WERE ORDERED AND RESULTS ALLEGEDLY SHOWED COBALT AT 17.5 AND CHROMIUM AT 6.1. ALLEGEDLY DURING THE REVISION SURGERY ON (B)(6) 2025, THE BALL COMPONENT WAS REPLACED WITH CLEANSING THE JOINT OF COBALT DEBRIS.
Patient problems: High metal ion levels; Metal Related Pathology
MAUDE report 24303035 ↗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 ↗InjuryMar 5, 2025Loss of Osseointegration; Loss of Osseointegration
THE FOLLOWING WAS REPORTED: TOTAL ASEPTIC LOOSENING.
Patient problems: Inadequate Osseointegration
MAUDE report 21525012 ↗InjuryJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2011 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ABGII CEMENTLESS HIP STEM. HIS LEFT HIP WAS REVISED ON (B)(6) 2023 ALLEGEDLY DUE TO HEAD DISASSOCIATION.
Patient problems: Insufficient Information
MAUDE report 21081839 ↗InjuryMar 28, 2024Fracture; Fracture
THE FOLLOWING WAS REPORTED: BROKEN ABG II STEM. ABG STEM WAS BROKEN WHEN IMPLANT WAS IN SITU, BECAUSE THE STEM WAS BROKEN THE PATIENT NEEDS TO BE REVISED.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 19001230 ↗InjuryApr 14, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
PROSTHETIC STEM COLLAR BREAKING. PATIENT WITH CLEAR SURGICAL WOUND AFTER REVIEW OF RIGHT HIP PROSTHESIS FOR COLLAR BREAK. SURGICAL WOUND DEHISCENCE AFTER RIGHT HIP PROSTHESIS REVISION. UPDATE : THE SURGICAL WOUND DEHISCENCE MENTIONED IN THE REPORTED DETAILS REFERS TO AN ADVERSE EVENT THAT OCCURRED POST-REVISION OF STRYKER DEVICES. THE PATIENT WAS LATER REVISED ON (B)(6) 2023 (COMPETITOR DEVICES) DUE TO INFECTION/WOUND DEHISCENCE. THIS PI IS FOR THE REVISION OF STRYKER PRODUCTS WHICH OCCURRED ON (B)(6) 2023 DUE TO STEM FRACTURE DURING WHICH COMPETITOR DEVICES WERE IMPLANTED.
Patient problems: Insufficient Information; Wound Dehiscence
MAUDE report 16741074 ↗InjuryMar 8, 2023Degraded; Material Erosion; Degraded; Material Erosion
InjuryFeb 26, 2023Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component
OUR AGENT REPORTED: "AN ABG STEM IMPLANT WITH MITCH, IMPLANTED OVER 11 YEARS AGO, HAS BEEN REVISED. THE LARGE HEAD CONSUMED THE MORSE TAPER OF THE STEM CAUSING DISLOCATION OF THE HEAD AND NECESSITATING THE REMOVAL OF THE STEM AND REIMPLANTATION OF A MODULAR RESTORATION WITH MDM".
Patient problems: Joint Dislocation; Metal Related Pathology; Necrosis
MAUDE report 16441456 ↗InjuryNov 30, 2022Fracture; Fracture
ON (B)(6) 2022 IN A PATIENT WAS ADMITTED TO THE SURGICAL AND ORTHOPEDIC WARD AS AN EMERGENCY AS A RESULT OF A TRANSFER BY THE EMERGENCY MEDICAL TEAM. AFTER AN X-RAY EXAMINATION, THE PATIENT WAS FOUND TO HAVE AN ABG STEM FRACTURE OF THE RIGHT HIP. THE ABG STEM IN 2008. ON (B)(6) 2022 REVISION SURGERY OF THE RIGHT HIP JOINT WAS PERFORMED (REMOVAL OF THE ABG ENDOPROSTHESIS STEM REMOVAL OF THE CAP HEAD. OPEN SETTING OF THE FRACTURE WITH INTERNAL STABILIZATION (FEMUR)). REPLACEMENT OF THE STEM AND FEMORAL HEAD WAS PERFORMED. THERE IS A DRILLING ON THE STEM, (A HOLE) WHICH WAS MADE TO REMOVE THE STEM DURING THE SURGERY.
Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s)
MAUDE report 15885896 ↗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 ↗InjurySep 30, 2021Degraded; Fracture; Degraded; Fracture
THE PATIENT REPORTED TO THE HOSPITAL AND WAS ADMITTED TO THE ORTHOPEDICS DEPARTMENT DUE TO PAIN AND LIMB SHORTENING. THE PERFORMED DIAGNOSTICS REVEALED INCORRECT POSITIONING OF THE HIP JOINT PROSTHESIS COMPONENTS, IN PARTICULAR THE STEM AND HEAD (SUSPECTED STEM FRACTURE). DURING THE REVISION OF THE HIP ARTHROPLASTY, A PARTIAL FRACTURE OF THE STEM CONE AND SIGNIFICANT ABRASION ON THE SURFACES OF THE STEM CONE, HEAD AND POLYETHYLENE INSERT WAS REPORTED. DURING THE REVISION PROCEDURE, THE PATIENT WAS FITTED WITH THE STRYKER SYSTEM: RESTORATION MODULAR STEM, CERAMIC HEAD, POLYETHYLENE INSERT. DUE TO THE CORRECT SEATING, THE ACETABULAR ELEMENT WAS LEFT IN THE OPERATOR'S DECISION.
Patient problems: Ambulation or Postural Difficulties; Pain; Unequal Limb Length
MAUDE report 12553241 ↗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 25, 2020Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
PATIENT GOT A RIGHT HIP REVISION DUE TO ¿SQUEAKING¿ COMPLAINTS. PATIENT COMPLAINT OF GRINDING, POPPING FEELING AND AUDIBLE SQUEAK AND GRINDING. PATIENT ALSO EXPERIENCING PAIN. CUP AND LINER WERE WELL FIXATED. HEAD EASILY REMOVED FROM TRUNNION. NO MARKED STRIPING ON CERAMIC LINER OR OUTER HEAD - BUT BROWN DISCOLOURATION INSIDE HEAD. HEAD LOOSE ON TRUNNION. RUST MARKS ON CUP RIM. FEMORAL STEM UNREMARKABLE, FIXATED AND RETAINED.
Patient problems: Pain
MAUDE report 10903549 ↗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 Howmedica Osteonics Corp. products
- Triathlon608 models · 3,524 reports · 15 recalls
- Scorpio107 models · 113 reports · 28 recalls
- Trident160 models · 1,280 reports · 2 recalls
- Accolade57 models · 1,228 reports
- Duracon58 models · 65 reports · 16 recalls
- LFIT23 models · 852 reports
- TRIDENT II42 models · 188 reports · 12 recalls
- INSTRUMENT131 models · 290 reports · 7 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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