ESC PINNACLERecalls & reported problems across all models
Depuy (Ireland) · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 175
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 5 models of ESC PINNACLE by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 175 adverse event reports in the FDA's MAUDE database, received between Sep 8, 2017 and Sep 29, 2026 — classified as 1 injury, 174 malfunctions.
The most frequently reported specific device problem is “Break” (88 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 ESC PINNACLE problems
Device problems
- Break88
- Material Deformation63
- Material Twisted/Bent19
- Bent9
- Device-Device Incompatibility4
- Naturally Worn4
- No Apparent Adverse Event4
- Crack3
Patient problems
- No Clinical Signs, Symptoms or Conditions103
- No Consequences Or Impact To Patient53
- Insufficient Information13
- No Information8
- No Code Available3
- Joint Laxity1
ESC PINNACLE models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ESC PINNACLE 2218-00-010EXTRACTOR151 reports
- ESC PINNACLE 2218-00-020DRIVER, PROSTHESIS19 reports
- ESC PINNACLE 2218-00-028DRIVER, PROSTHESIS2 reports
- ESC PINNACLE 2218-00-036DRIVER, PROSTHESIS2 reports
- ESC PINNACLE 2217-60-063TRAY, SURGICAL, INSTRUMENT1 report
Recent ESC PINNACLE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936426 ↗MalfunctionSep 11, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735152 ↗MalfunctionSep 2, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555087 ↗MalfunctionSep 2, 2026Material Deformation
It was reported that 2X ESC liner tips were bent while extracting a metal liner.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555085 ↗MalfunctionMay 26, 2026Break
IT WAS REPORTED THAT DURING INSPECTION OF THE DEVICE IT WAS OBSERVED THAT THE TIP OF THE TOOL WAS BROKEN OFF AND UNABLE TO BE USED. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279573 ↗MalfunctionApr 29, 2026Break
DURING A HIP SURGERY, THE DR WAS PUTTING THE RETAINING RING ON AN ES CONSTRAINED LINER WHEN THE HANDLE OF THE RETAINING RING INSERTER BROKE. HE WAS STILL ABLE TO USE THE INSERTER TO COMPLETE THE CASE AND THERE WAS NO DELAY. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, IF YES, NUMBER OF MINUTES: 0. ACTION TAKEN WHEN EVENT OCCURRED? THE SURGEON USED TO INSERTER TO PUT THE RETAINING RING ON THE CONSTRAINED LINER, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035163 ↗MalfunctionApr 9, 2026No Apparent Adverse Event
IT WAS REPORTED THE DEVICE WAS FOUND BROKEN DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832625 ↗MalfunctionApr 7, 2026Break; Material Deformation
IT WAS REPORTED THAT THE TIP OF AN EXTRACTOR WAS BENT AND BROKEN. THE EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802718 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT THE TIP OF LINER REMOVAL TOOL WAS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756140 ↗MalfunctionFeb 24, 2026Break
IT WAS REPORTED THAT PINNACLE CONSTRAINED SPIKE TOOL BROKE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431133 ↗MalfunctionFeb 16, 2026Break
IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343474 ↗MalfunctionJan 23, 2026Material Deformation
IT WAS REPORTED THAT THE TIP OF THE PINNACLE LINER EXTRACTOR IS BENT AND UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24164526 ↗MalfunctionJan 20, 2026Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF THE HIP IT WAS OBSERVED THAT HANDLE SNAPPED WHILE IMPACTING LOCKING RING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24117249 ↗MalfunctionJan 16, 2026Material Deformation
IT WAS REPORTED THAT TIP WAS BENT. CUSTOMER REQUESTED TO REPLACE THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24094634 ↗MalfunctionJan 16, 2026Material Deformation
IT WAS REPORTED THAT INSTRUMENT TIP WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093862 ↗
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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