ESC PINNACLE 2218-00-010Recalls & reported problems
Depuy (Ireland) · PINNACLE ESC LINER EXTRACTOR TIP · Class 1
All models of ESC PINNACLE (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle liner extractor tip is a surgical tool used to remove hip implant liners. Its 147 reports describe the tip breaking, bending, or deforming, and most report no effect on patients. The reports include no injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 151
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 10603295099505), received between Sep 8, 2017 and Sep 29, 2026 — classified as 151 malfunctions.
The most frequently reported specific device problem is “Break” (72 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break72
- Material Deformation62
- Material Twisted/Bent17
- Bent9
- Naturally Worn4
- Crack2
- Material Integrity Problem2
- No Apparent Adverse Event2
Patient problems
- No Clinical Signs, Symptoms or Conditions90
- No Consequences Or Impact To Patient47
- Insufficient Information10
- No Information7
- No Code Available3
Recent adverse event reports
The 25 most recent of 151 reports, 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 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 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 ↗MalfunctionJan 6, 2026Break; Material Deformation
THE REPORTED THAT THE PINN ESC LINER EXTRACTOR TIP WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23976169 ↗MalfunctionDec 15, 2025Break; Break
ADDITIONAL INFORMATION STATES 887907959411.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23802903 ↗MalfunctionDec 10, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS NOTICED TO BE BROKEN WHILE OPENING FOR THE CASE. IT DID NOT HAPPEN DURING THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23766886 ↗MalfunctionDec 3, 2025Material Deformation; Material Deformation
ADDITIONAL INFORMATION RECEIVED STATES THAT THE TIP WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23703795 ↗MalfunctionNov 19, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT WHILE TRYING TO REMOVE THE LINER, THE CONSTRAINED LINER REMOVAL TOOL WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597023 ↗MalfunctionNov 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TIPS ON BOTH INSTRUMENTS WERE BENT AND WORN. THE WAS NO HOSPITAL INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23581084 ↗MalfunctionNov 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TIPS ON BOTH INSTRUMENTS WERE BENT AND WORN. THE WAS NO HOSPITAL INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23581058 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT TIP OF LINER EXTRACTOR WAS BROKEN OFF. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23512675 ↗MalfunctionNov 5, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. IT WAS NOTICED DURING MANUFACTURERS INVESTIGATION THAT THE INSTRUMENT WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23478622 ↗MalfunctionNov 5, 2025Break; Break
IT WAS REPORTED THAT WHILE TRYING TO REMOVE THE CERAMIC LINER FROM THE PATIENT, THE TIP OF THE REMOVAL PIECE WAS BROKEN. THIS DID NOT IMPACT THE LENGTH OF THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476069 ↗MalfunctionNov 5, 2025Break; Break
IT WAS REPORTED THAT WHILE TRYING TO REMOVE THE CERAMIC LINER FROM THE PATIENT, THE TIP OF THE REMOVAL PIECE WAS BROKEN. THIS DID NOT IMPACT THE LENGTH OF THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476062 ↗MalfunctionOct 28, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT 2 LINER EXTRACTION TIPS WERE BENT OR BROKEN DURING SURGERY. ALL PIECES WERE RETRIEVED AND THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402689 ↗
Other EXTRACTOR devices
- ATTUNE 2545-00-138Depuy (Ireland) · EXTRACTOR392 reports
- PINNACLE 2217-50-001Depuy (Ireland) · EXTRACTOR243 reports
- RECLAIM 2975-00-635Depuy (Ireland) · EXTRACTOR157 reports
- ATTUNE 2545-00-060Depuy (Ireland) · EXTRACTOR153 reports
- NA 2125-00-600Depuy Orthopaedics, Inc. · EXTRACTOR130 reports
- P.F.C. 86-5226Depuy (Ireland) · EXTRACTOR80 reports
- NA 03.010.000Synthes GmbH · EXTRACTOR74 reports
- LPS 2987-72-030Depuy (Ireland) · EXTRACTOR68 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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