INHANCERecalls & reported problems across all models
Depuy (Ireland) · 202 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,578
- Deaths reported
- 0
- Injuries reported
- 1,003
- Recalls
- 0
We found 202 models of INHANCE by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 4,578 adverse event reports in the FDA's MAUDE database, received between Oct 21, 2021 and Sep 30, 2026 — classified as 1,003 injuries, 3,575 malfunctions.
The most frequently reported specific device problem is “Break” (1,555 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 INHANCE problems
Device problems
- Break1,555
- Device-Device Incompatibility812
- Naturally Worn760
- Material Deformation756
- Adverse Event Without Identified Device or Use Problem714
- Device Dislodged or Dislocated195
- Crack168
- No Apparent Adverse Event108
Patient problems
- No Clinical Signs, Symptoms or Conditions3,006
- Insufficient Information686
- Unspecified Infection245
- Joint Laxity218
- Unspecified Tissue Injury195
- Joint Dislocation160
- Pain91
- Bone Fracture(s)53
INHANCE models
202 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- INHANCE 6500-11-104Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Orthopedic manual surgical instrument567 reports
- INHANCE 6205-10-103IMPACTOR337 reports
- INHANCE 6505-10-103Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment209 reports
- INHANCE 6205-10-105DRIVER, PROSTHESIS191 reports
- INHANCE 6201-20-121TEMPLATE182 reports
- INHANCE 6200-10-001TEMPLATE152 reports
- INHANCE 6201-01-121PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED98 reports
- INHANCE 5120-00-110prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- INHANCE 5500-36-000PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED64 reports
- INHANCE 6205-10-101ORTHOPEDIC MANUAL SURGICAL INSTRUMENT58 reports
- INHANCE 5500-00-400PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED58 reports
- INHANCE 5505-36-004PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED55 reports
- INHANCE 6500-11-103Orthopedic manual surgical instrument48 reports
- INHANCE 6200-10-002TEMPLATE44 reports
- INHANCE 6201-01-141IMPACTOR40 reports
- INHANCE 6205-10-104IMPACTOR39 reports
- INHANCE 6205-10-102Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment33 reports
- INHANCE 6200-48-170TEMPLATE30 reports
- INHANCE 5500-00-360prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented30 reports
- INHANCE 5505-36-008PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED29 reports
- INHANCE 6105-10-030TEMPLATE26 reports
- INHANCE 5505-32-004PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED24 reports
- INHANCE 5500-36-100prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented24 reports
- INHANCE 6500-36-000TEMPLATE24 reports
- INHANCE 5100-24-000PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED23 reports
- INHANCE 5500-36-004prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented23 reports
- INHANCE 5503-00-500PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED23 reports
- INHANCE 6205-10-106ORTHOPEDIC MANUAL SURGICAL INSTRUMENT22 reports
- INHANCE 5503-10-025PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED22 reports
- INHANCE 6200-46-160TEMPLATE21 reports
- INHANCE 6200-51-180TEMPLATE21 reports
- INHANCE 5503-10-020PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED21 reports
- INHANCE 6200-30-040TEMPLATE20 reports
- INHANCE 6500-32-100TEMPLATE20 reports
- INHANCE 6200-10-003PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED19 reports
- INHANCE 6500-11-101Orthopedic manual surgical instrument19 reports
- INHANCE 5500-00-320PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED18 reports
- INHANCE 6500-36-100TEMPLATE18 reports
- INHANCE 5100-26-500prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented17 reports
- INHANCE 5200-00-036Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained17 reports
- INHANCE 5500-01-240PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED17 reports
- INHANCE 5500-40-000shoulder prosthesis, reverse configuration17 reports
- INHANCE 6205-60-030DRIVER, PROSTHESIS16 reports
- INHANCE 5500-36-104shoulder prosthesis, reverse configuration16 reports
- INHANCE 5500-35-600PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED16 reports
- INHANCE 5500-11-240prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented16 reports
- INHANCE 5200-01-040PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED15 reports
- INHANCE 6201-01-151DRIVER, PROSTHESIS15 reports
- INHANCE 5500-32-000PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED15 reports
- INHANCE 6500-32-000TEMPLATE15 reports
- INHANCE 5503-10-015prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented14 reports
- INHANCE 5500-00-368PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED14 reports
- INHANCE 5505-36-104prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented14 reports
- INHANCE 6105-10-050TEMPLATE13 reports
- INHANCE 6205-10-107ORTHOPEDIC MANUAL SURGICAL INSTRUMENT13 reports
- INHANCE 6205-60-050DRIVER, PROSTHESIS13 reports
- INHANCE 5500-32-004PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED13 reports
- INHANCE 5505-40-004prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented13 reports
- INHANCE 5200-01-036PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED12 reports
- INHANCE 5200-00-040prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented12 reports
- INHANCE 5200-46-160PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED12 reports
- INHANCE 6200-30-028TEMPLATE12 reports
- INHANCE 6200-30-036TEMPLATE12 reports
- INHANCE 6200-44-152TEMPLATE12 reports
- INHANCE 6200-51-205TEMPLATE12 reports
- INHANCE 6201-01-161IMPACTOR12 reports
- INHANCE 6205-60-040DRIVER, PROSTHESIS12 reports
- INHANCE 5505-32-008prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented12 reports
- INHANCE 5500-32-100PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED12 reports
- INHANCE 5100-29-000PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED11 reports
- INHANCE 5200-48-170PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED11 reports
- INHANCE 6105-10-040TEMPLATE11 reports
- INHANCE 6200-30-032TEMPLATE11 reports
- INHANCE 5500-40-100PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED11 reports
- INHANCE 5503-10-035PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED11 reports
- INHANCE 5505-40-008shoulder prosthesis, reverse configuration11 reports
- INHANCE 6500-40-000TEMPLATE11 reports
- INHANCE 5503-10-030PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED10 reports
- INHANCE 5500-01-290prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented10 reports
- INHANCE 5500-40-004prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented10 reports
- INHANCE 5500-00-408PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED10 reports
- INHANCE 5500-00-440PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED10 reports
- INHANCE 5200-44-152PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED9 reports
- INHANCE 6200-30-044TEMPLATE9 reports
- INHANCE 6200-48-195TEMPLATE9 reports
- INHANCE 6500-40-100TEMPLATE9 reports
- INHANCE 5500-25-600PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED9 reports
- INHANCE 5100-26-522PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED9 reports
- INHANCE 5100-21-500PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED8 reports
- INHANCE 6200-54-190TEMPLATE8 reports
- INHANCE 5500-40-104PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED8 reports
- INHANCE 5505-40-104PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED8 reports
- INHANCE 6500-36-004TEMPLATE8 reports
- INHANCE 5500-30-600PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED8 reports
- INHANCE 7505-10-103DRIVER, PROSTHESIS8 reports
- INHANCE 5200-40-137PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED7 reports
- INHANCE 5200-46-185PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED7 reports
- INHANCE 5200-51-180PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED7 reports
- INHANCE 6105-10-020TEMPLATE7 reports
Recent INHANCE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
It was reported that an artificial shoulder joint surgery for CTA was performed on (b)(6) 2026. During the surgery, the IMPACTOR TIP broke while in use. The surgery was completed without issues. There was no surgical delay. There was no harm to the patient. No device remained in the patient. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947461 ↗MalfunctionSep 30, 2026Break
It was reported that the INHANCE device was dull and missing one of the tips. It was reported that the event did not happen in surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946037 ↗MalfunctionSep 30, 2026Break; Device-Device Incompatibility
It was reported that the version indicator was damaged during decontamination process. Plastic clip was broken and will no longer affix to stem inserter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946027 ↗MalfunctionSep 30, 2026Break
It was reported that during Shoulder Repair surgery, the version indicator broke into 2 pieces when impacting humeral stem. All pieces retrieved. Please send a replacement to office.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945500 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the revised was performed due to instability following a post op fracture causing the stem to loosen and it was stated that the humeral stem was loose and at the bone to implant interface.DOI-(b)(6)2026.DOR-(b)(6)2026.Affected side-Right.
Patient problems: Joint Laxity
MAUDE report 50944899 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the revised was performed due to instability following a post op fracture causing the stem to loosen and it was stated that the humeral stem was loose and at the bone to implant interface.DOI - (b)(6)2026.DOR - (b)(6)2026.Affected side -Right.
Patient problems: Joint Laxity
MAUDE report 50944877 ↗InjurySep 30, 2026Osseointegration Problem
It was reported that the revised was performed due to instability following a post op fracture causing the stem to loosen and it was stated that the humeral stem was loose and at the bone to implant interface.DOI-(b)(6)2026.DOR-(b)(6)2026.Affected side-Right.
Patient problems: Inadequate Osseointegration; Joint Laxity
MAUDE report 50944858 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the revised was performed due to instability following a post op fracture causing the stem to loosen and it was stated that the humeral stem was loose and at the bone to implant interface.DOI-(b)(6)2026.DOR-(b)(6)2026.Affected side-Right.
Patient problems: Joint Laxity
MAUDE report 50944844 ↗InjurySep 29, 2026Device Dislodged or Dislocated
Patient problems: Insufficient Information
MAUDE report 50933355 ↗InjurySep 29, 2026Device Dislodged or Dislocated
It was reported that Glenoshpere disengaged from baseplate. Revision surgery removed poly and glenosphere and replaced with new components.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected Side: Right Shoulder.
Patient problems: Insufficient Information
MAUDE report 50933182 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933102 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933096 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931071 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928688 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919692 ↗
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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