HudsonRecalls & reported problems across all models
Stryker Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 77
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 4 models of Hudson by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 77 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2018 and Apr 22, 2026 — classified as 2 injuries, 75 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (39 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 Hudson problems
Device problems
- Detachment of Device or Device Component39
- Fracture14
- Fluid/Blood Leak10
- Material Disintegration5
- Overheating of Device5
- Material Fragmentation3
- Adverse Event Without Identified Device or Use Problem1
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions61
- No Patient Involvement18
- Foreign Body In Patient2
- Insufficient Information2
- Abrasion1
- Bone Fracture(s)1
- Device Embedded In Tissue or Plaque1
- Infiltration into Tissue1
Hudson models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Hudson 6203135000INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT28 reports
- Hudson 4100135000INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT17 reports
- Hudson 4100235000INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT17 reports
- Hudson 6203113000INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT15 reports
Recent Hudson adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Detachment of Device or Device Component
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953979 ↗MalfunctionApr 3, 2026
WHILE DR. WAS ATTEMPTING TO USE THE REAMER INSTRUMENT, THE REGULAR HUDSON ATTACHMENT BROKE INTO TWO PIECES. THE INSTRUMENT AND HUDSON PIECE WERE THEN PASSED OFF THE STERILE FIELD. REPAIR TAG APPLIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775861 ↗MalfunctionOct 28, 2025Material Fragmentation; Material Fragmentation
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL FRAGMENTATION - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23399937 ↗MalfunctionOct 28, 2025Material Disintegration; Material Disintegration
MalfunctionJul 29, 2025Material Fragmentation; Material Fragmentation
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL FRAGMENTATION. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22646529 ↗MalfunctionApr 21, 2025Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 2 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21878627 ↗MalfunctionApr 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - 2 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876848 ↗MalfunctionApr 21, 2025Material Disintegration; Material Disintegration
THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. - 5 EVENTS HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876067 ↗MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21207663 ↗MalfunctionJan 21, 2025Fracture; Fracture
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21201186 ↗MalfunctionJan 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED REGARDING HEALTH IMPACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21200900 ↗InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS DETERMINED TO HAVE A FRACTURED TIBIAL PLATEAU, 10 DAYS AFTER A HEMI-KNEE SURGERY INVOLVING THIS DEVICE. THE PATIENT WILL UNDERGO A REVISION SURGERY.
Patient problems: Bone Fracture(s)
MAUDE report 20847415 ↗MalfunctionOct 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20501552 ↗MalfunctionOct 21, 2024Fracture; Fracture
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 20501054 ↗MalfunctionOct 21, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 1 EVENT HAD HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20500973 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 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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