EMPHASYSRecalls & reported problems across all models
Depuy (Ireland) · 109 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 812
- Deaths reported
- 0
- Injuries reported
- 215
- Recalls
- 0
We found 109 models of EMPHASYS by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 812 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2022 and Sep 30, 2026 — classified as 215 injuries, 597 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (288 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 EMPHASYS problems
Device problems
- Device-Device Incompatibility288
- Material Deformation171
- Adverse Event Without Identified Device or Use Problem158
- Break141
- Naturally Worn41
- Crack30
- Device Dislodged or Dislocated24
- Osseointegration Problem20
Patient problems
- No Clinical Signs, Symptoms or Conditions500
- Insufficient Information126
- Unspecified Infection93
- Joint Dislocation22
- Inadequate Osseointegration20
- Limb Fracture19
- Joint Laxity17
- Pain15
EMPHASYS models
109 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- EMPHASYS 4812-01-150IMPACTOR212 reports
- EMPHASYS 4812-01-550IMPACTOR89 reports
- EMPHASYS 4814-36-050IMPACTOR68 reports
- EMPHASYS 4814-40-050IMPACTOR41 reports
- EMPHASYS 4814-00-050IMPACTOR35 reports
- EMPHASYS 4710-48-300Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented24 reports
- EMPHASYS 4710-52-300PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED17 reports
- EMPHASYS 4710-50-300Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented16 reports
- EMPHASYS 4710-56-300PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED15 reports
- EMPHASYS 4710-54-300PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED14 reports
- EMPHASYS 4725-50-040Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented10 reports
- EMPHASYS 4722-46-032Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented10 reports
- EMPHASYS 4814-32-050IMPACTOR9 reports
- EMPHASYS 4813-00-000TEMPLATE9 reports
- EMPHASYS 4742-07-200Prosthesis, hip, hemi-, femoral, metal8 reports
- EMPHASYS 4732-40-028PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED8 reports
- EMPHASYS 4710-58-300Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented7 reports
- EMPHASYS 4725-54-044Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6 reports
- EMPHASYS 4732-46-028PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- EMPHASYS 4725-52-042PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- EMPHASYS 4710-56-900PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- EMPHASYS 4742-05-200Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate5 reports
- EMPHASYS 4742-06-200Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented5 reports
- EMPHASYS 4822-48-036TEMPLATE5 reports
- EMPHASYS 4852-07-100TEMPLATE5 reports
- EMPHASYS 4732-42-028Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- EMPHASYS 4732-44-028Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- EMPHASYS 4710-46-300PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- EMPHASYS 4710-60-300Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- EMPHASYS 4725-48-038PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- EMPHASYS 4725-56-046PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- EMPHASYS 4710-48-000Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- EMPHASYS 4822-56-436TEMPLATE4 reports
- EMPHASYS 4851-05-100TEMPLATE4 reports
- EMPHASYS 4864-00-020IMPACTOR4 reports
- EMPHASYS 4819-22-090Orthopedic manual surgical instrument4 reports
- EMPHASYS 4732-38-028Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- EMPHASYS 4710-52-900PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- EMPHASYS 4742-08-200Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- EMPHASYS 4822-56-036TEMPLATE3 reports
- EMPHASYS 4822-52-236TEMPLATE3 reports
- EMPHASYS 4822-52-040TEMPLATE3 reports
- EMPHASYS 4840-07-100Instruments designed for press-fit osteochondral implants3 reports
- EMPHASYS 4851-01-100TEMPLATE3 reports
- EMPHASYS 4851-03-100TEMPLATE3 reports
- EMPHASYS 4851-07-100TEMPLATE3 reports
- EMPHASYS 4851-09-100TEMPLATE3 reports
- EMPHASYS 4851-11-100TEMPLATE3 reports
- EMPHASYS 4852-01-100TEMPLATE3 reports
- EMPHASYS 4852-03-100TEMPLATE3 reports
- EMPHASYS 4852-05-100TEMPLATE3 reports
- EMPHASYS 4852-09-100TEMPLATE3 reports
- EMPHASYS 4852-11-100TEMPLATE3 reports
- EMPHASYS 4830-38-028TEMPLATE3 reports
- EMPHASYS 4732-48-036Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- EMPHASYS 4813-00-550TEMPLATE3 reports
- EMPHASYS 4725-46-036PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- EMPHASYS 4725-60-048Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- EMPHASYS 4722-44-032PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- EMPHASYS 4710-48-900PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- EMPHASYS 4710-60-900Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- EMPHASYS 4810-50-900TEMPLATE2 reports
- EMPHASYS 4741-09-200Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- EMPHASYS 4742-03-200Prosthesis, hip, hemi-, femoral, metal2 reports
- EMPHASYS 4742-04-200Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- EMPHASYS 4822-50-236TEMPLATE2 reports
- EMPHASYS 4822-54-036TEMPLATE2 reports
- EMPHASYS 4822-52-036TEMPLATE2 reports
- EMPHASYS 4822-50-036TEMPLATE2 reports
- EMPHASYS 4840-03-100Instruments designed for press-fit osteochondral implants2 reports
- EMPHASYS 4864-00-010IMPACTOR2 reports
- EMPHASYS 4819-32-090Orthopedic manual surgical instrument2 reports
- EMPHASYS 4825-54-044TEMPLATE2 reports
- EMPHASYS 4732-36-022PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- EMPHASYS 4722-44-232PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- EMPHASYS 4710-50-900Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- EMPHASYS 4710-50-000Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- EMPHASYS 4810-60-900TEMPLATE1 report
- EMPHASYS 4810-53-900TEMPLATE1 report
- EMPHASYS 4810-54-900TEMPLATE1 report
- EMPHASYS 4810-55-900TEMPLATE1 report
- EMPHASYS 4810-56-900TEMPLATE1 report
- EMPHASYS 4810-58-900TEMPLATE1 report
- EMPHASYS 4821-48-436TEMPLATE1 report
- EMPHASYS 4741-03-200Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- EMPHASYS 4741-05-200Prosthesis, hip, hemi-, femoral, metal1 report
- EMPHASYS 4742-10-200Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate1 report
- EMPHASYS 4742-07-100Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- EMPHASYS 4742-08-100Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- EMPHASYS 4822-60-036TEMPLATE1 report
- EMPHASYS 4822-48-436TEMPLATE1 report
- EMPHASYS 4822-50-436TEMPLATE1 report
- EMPHASYS 4822-54-040TEMPLATE1 report
- EMPHASYS 4822-54-440TEMPLATE1 report
- EMPHASYS 4822-56-440TEMPLATE1 report
- EMPHASYS 4840-01-100Instruments designed for press-fit osteochondral implants1 report
- EMPHASYS 4840-05-100Instruments designed for press-fit osteochondral implants1 report
- EMPHASYS 4840-06-100Instruments designed for press-fit osteochondral implants1 report
- EMPHASYS 4840-09-100Instruments designed for press-fit osteochondral implants1 report
- EMPHASYS 4840-10-100Instruments designed for press-fit osteochondral implants1 report
Recent EMPHASYS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device-Device Incompatibility
It was reported that the emphasys impactor threaded part no longer threads.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946332 ↗MalfunctionSep 30, 2026Material Deformation
It was reported that the emphasys straight manual impactor handle was cross threaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946177 ↗InjurySep 30, 2026Device Dislodged or Dislocated
It was reported that replaced original stem with one larger in size and changed out the poly liner and head.DOI-Unknown.DOR-(b)(6)2026.Affected side-Unknown.
Patient problems: Joint Dislocation
MAUDE report 50945334 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pain
MAUDE report 50935277 ↗MalfunctionSep 29, 2026Material Deformation
It was reported that when the tech was putting the size 36 head impactor tip onto the adapter and impactor handle, the internal threads of the impactor tip became stripped. There was no issues or delays were caused.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931279 ↗MalfunctionSep 29, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931163 ↗MalfunctionSep 28, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921762 ↗MalfunctionSep 25, 2026Break; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903436 ↗InjurySep 24, 2026Use of Device Problem; Improper or Incorrect Procedure or Method
It was reported that the patient underwent the revision of an Emphasys cup due to dislocation. The cup was reported to have been implanted too steep/open and retroverted, and the event was described as surgeon error rather than implant fault.
Patient problems: Insufficient Information
MAUDE report 50884872 ↗MalfunctionSep 23, 2026Device-Device Incompatibility
It was reported that implant gets stuck on threads.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870660 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was revised due to suspected infection.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right Hip.
Patient problems: Unspecified Infection
MAUDE report 50854073 ↗MalfunctionSep 21, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848636 ↗MalfunctionSep 21, 2026Device-Device Incompatibility; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846485 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828583 ↗MalfunctionSep 18, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824056 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →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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