ACTISRecalls & reported problems across all models
Depuy (Ireland) · 97 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,973
- Deaths reported
- 1
- Injuries reported
- 653
- Recalls
- 1
We found 97 models of ACTIS by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 2,973 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2017 and Sep 30, 2026 — classified as 1 death, 653 injuries, 2,319 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (926 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
ACTIS recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 25, 2016Terminated
DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.
Z-0650-2017 · Root cause: Under Investigation by firm · names 7 of these models · Recall details · FDA record ↗
Most reported ACTIS problems
Device problems
- Device-Device Incompatibility926
- Break796
- Adverse Event Without Identified Device or Use Problem463
- Material Deformation197
- Failure to Cut194
- Scratched Material168
- Material Twisted/Bent133
- Naturally Worn131
Patient problems
- No Clinical Signs, Symptoms or Conditions1,561
- No Consequences Or Impact To Patient457
- Insufficient Information234
- Unspecified Infection222
- Limb Fracture180
- No Code Available170
- Inadequate Osseointegration111
- Fall100
ACTIS models
97 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACTIS 2010-01-050BROACH235 reports
- ACTIS 2010-07-100ORTHOPEDIC MANUAL SURGICAL INSTRUMENT209 reports
- ACTIS 2010-01-060BROACH186 reports
- ACTIS 2010-01-040BROACH172 reports
- ACTIS 2010-01-070BROACH162 reports
- ACTIS 2010-01-030BROACH131 reports
- ACTIS 2010-01-080BROACH108 reports
- ACTIS 2010-01-020BROACH94 reports
- ACTIS 2010-01-010BROACH87 reports
- ACTIS 101011050Prosthesis, hip, hemi-, femoral, metal73 reports
- ACTIS 2010-01-090BROACH73 reports
- ACTIS 101011060Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- ACTIS 2010-04-200TRAY, SURGICAL, INSTRUMENT66 reports
- ACTIS 2010-01-100BROACH62 reports
- ACTIS 101012060PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED61 reports
- ACTIS 101011040Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 death60 reports
- ACTIS 101012040Prosthesis, hip, hemi-, femoral, metal58 reports
- ACTIS 101012050PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED57 reports
- ACTIS 2010-01-005BROACH57 reports
- ACTIS 2010-01-120BROACH53 reports
- ACTIS 2010-07-120ORTHOPEDIC MANUAL SURGICAL INSTRUMENT50 reports
- ACTIS 2010-01-210REAMER1 recall0 reports
- ACTIS 2010-01-260REAMER1 recall0 reports
- ACTIS 2010-01-270REAMER1 recall0 reports
- ACTIS 2010-01-230REAMER1 recall0 reports
- ACTIS 2010-01-240REAMER1 recall0 reports
- ACTIS 2010-01-250REAMER1 recall0 reports
- ACTIS 2010-01-220REAMER1 recall0 reports
- ACTIS 101012070Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate47 reports
- ACTIS 2010-07-110ORTHOPEDIC MANUAL SURGICAL INSTRUMENT47 reports
- ACTIS 2010-01-002BROACH46 reports
- ACTIS 2010-01-110BROACH45 reports
- ACTIS 101011070PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED44 reports
- ACTIS 101011030Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented38 reports
- ACTIS 101011080Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate35 reports
- ACTIS 101012080Prosthesis, hip, hemi-, femoral, metal32 reports
- ACTIS 101012030Prosthesis, hip, hemi-, femoral, metal28 reports
- ACTIS 2010-04-500TRAY, SURGICAL, INSTRUMENT27 reports
- ACTIS 101012090Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented22 reports
- ACTIS 101011020Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate20 reports
- ACTIS 2010-02-300TEMPLATE20 reports
- ACTIS 2010-02-400TEMPLATE20 reports
- ACTIS 2010-02-450TEMPLATE20 reports
- ACTIS 2010-02-350TEMPLATE19 reports
- ACTIS 2010-02-500TEMPLATE17 reports
- ACTIS 2011-01-210Prosthesis, hip, hemi-, femoral, metal17 reports
- ACTIS 2010-02-200TEMPLATE16 reports
- ACTIS 2010-02-550TEMPLATE16 reports
- ACTIS 2010-02-100TEMPLATE15 reports
- ACTIS 2010-02-150TEMPLATE15 reports
- ACTIS 2010-02-250TEMPLATE15 reports
- ACTIS 2010-02-600TEMPLATE15 reports
- ACTIS 2010-02-650TEMPLATE15 reports
- ACTIS 101012100Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented14 reports
- ACTIS 3010-01-050Instruments designed for press-fit osteochondral implants14 reports
- ACTIS 3010-01-060Instruments designed for press-fit osteochondral implants14 reports
- ACTIS 3010-01-040Instruments designed for press-fit osteochondral implants12 reports
- ACTIS 3010-01-070Instruments designed for press-fit osteochondral implants12 reports
- ACTIS 101012020Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate11 reports
- ACTIS 101011090Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate9 reports
- ACTIS 2010-04-600TRAY, SURGICAL, INSTRUMENT8 reports
- ACTIS 2011-01-230Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate7 reports
- ACTIS 1010-21-060Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate7 reports
- ACTIS 3010-01-080Instruments designed for press-fit osteochondral implants7 reports
- ACTIS 2011-01-220Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate6 reports
- ACTIS 101011010PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- ACTIS 101011100Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate5 reports
- ACTIS 101012010Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented5 reports
- ACTIS 1010-21-070Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented5 reports
- ACTIS 3010-01-010Instruments designed for press-fit osteochondral implants5 reports
- ACTIS 1010-21-050Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate4 reports
- ACTIS 3010-01-020Instruments designed for press-fit osteochondral implants4 reports
- ACTIS 3010-01-030Instruments designed for press-fit osteochondral implants4 reports
- ACTIS 3010-01-090Instruments designed for press-fit osteochondral implants4 reports
- ACTIS 101012005Prosthesis, hip, hemi-, femoral, metal3 reports
- ACTIS 2011-01-240PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- ACTIS 2011-01-250Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
- ACTIS 1010-22-080Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate3 reports
- ACTIS 101011110Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- ACTIS 101012120PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- ACTIS 2011-01-260PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- ACTIS 1010-21-020Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- ACTIS 1010-21-030Prosthesis, hip, hemi-, femoral, metal2 reports
- ACTIS 1010-21-080Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate2 reports
- ACTIS 1010-22-050Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate2 reports
- ACTIS 1010-22-070Prosthesis, hip, hemi-, femoral, metal2 reports
- ACTIS 3010-01-005Instruments designed for press-fit osteochondral implants2 reports
- ACTIS 101012110Prosthesis, hip, hemi-, femoral, metal1 report
- ACTIS 101011120PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- ACTIS 2011-01-270Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- ACTIS 1010-21-040Prosthesis, hip, hemi-, femoral, metal1 report
- ACTIS 1010-21-090PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- ACTIS 1010-22-030Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- ACTIS 1010-22-040Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate1 report
- ACTIS 1010-22-090PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- ACTIS 3010-01-110Instruments designed for press-fit osteochondral implants1 report
- ACTIS 3010-01-120Instruments designed for press-fit osteochondral implants1 report
Recent ACTIS 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 50946330 ↗MalfunctionSep 29, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937741 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that Patient was revised for periprosthetic fracture.DOI: Unknown.DOR: (b)(6) 2026. Affected Side: Unknown Hip.
Patient problems: Limb Fracture
MAUDE report 50933443 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932500 ↗MalfunctionSep 29, 2026Break; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931313 ↗MalfunctionSep 29, 2026Break; Material Deformation
It was reported that threaded Actis distractor needs replaced asap. Threads were cross threaded and tip of other piece was broken. Osteotome handle also needs replaced. The locking mechanism was broken and no longer holds flex osteotomes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931311 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient comes in today with a hip fracture a couple months out of surgery. Dr removed the Actis Stem and head then went back in with a reclaim mono stem. No further patient information is available at this time.Affected side: Right hip.
Patient problems: Bone Fracture(s)
MAUDE report 50899931 ↗InjurySep 24, 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 50883165 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fall; Limb Fracture
MAUDE report 50873606 ↗MalfunctionSep 22, 2026Break
It was reported that the size 5 actis broach snapped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853258 ↗MalfunctionSep 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849534 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had a Left total hip done on (b)(6) 2026. Patient fell and had peri prosthetic fracture. The surgeon went to remove the Actis stem and put in a reclaim mono block.Affected side: Left hip.
Patient problems: Fall; Limb Fracture
MAUDE report 50838843 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that actis retaining stem inserter/extractor shaft broke in actis stem while trying to explant it. Removed stem due to infection, all pieces were retrieved no delay in case.Affected side: Right.
Patient problems: Unspecified Infection
MAUDE report 50816766 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was revised due to Infection.Affected Side: Left Hip.
Patient problems: Unspecified Infection
MAUDE report 50816385 ↗MalfunctionSep 17, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812046 ↗
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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