PINNACLE 2217-50-041Recalls & reported problems
Depuy (Ireland) · PINNACLE STRAIGHT CUP IMPACTOR · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle straight cup impactor is a surgical tool used to seat implant cups. Its 4,292 adverse event reports mostly describe broken, worn or bent parts, and some describe impactor handles breaking before surgery. The reports include no deaths and 3 injuries. 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
- 4,295
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,295 adverse event reports that list this exact device (DI 10603295098980), received between Jun 30, 2017 and Sep 30, 2026 — classified as 3 injuries, 4,292 malfunctions.
The most frequently reported specific device problem is “Break” (3,760 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
- Break3,760
- Naturally Worn248
- Material Deformation152
- Device-Device Incompatibility127
- Material Twisted/Bent99
- Crack63
- No Apparent Adverse Event37
- Scratched Material35
Patient problems
- No Clinical Signs, Symptoms or Conditions2,692
- No Consequences Or Impact To Patient1,169
- Insufficient Information323
- No Information95
- Not Applicable79
- No Code Available78
- Foreign Body In Patient5
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 25 most recent of 4,295 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
It was reported that the Pinnacle handle arrived broken. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947734 ↗MalfunctionSep 29, 2026Material Deformation
It was reported that cup handle cross threaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931165 ↗MalfunctionSep 25, 2026Break
It was reported that during an unknown surgery to attach the Pinnacle 100 Gription implant, the top threads on the cup impactor came loose and remained in the cup. The screw was loose and was removed easily. There was no meaningful impact on surgery time; it added approximately one minute. The Hole Eliminator was placed, and the surgery proceeded without complication. There was no reported patient or user harm. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896779 ↗MalfunctionSep 25, 2026Break
It was reported that during pre-surgery the hammerplate was broken. There was no significant delay. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896688 ↗MalfunctionSep 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885949 ↗MalfunctionSep 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885643 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873556 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873546 ↗MalfunctionSep 23, 2026Break
It was reported that there were broken items due to wear and tear.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873527 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873484 ↗MalfunctionSep 23, 2026Break
It was reported that two pinnacle handles have broken.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871728 ↗MalfunctionSep 23, 2026Break
It was reported that two pinnacle handles have broken.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871726 ↗MalfunctionSep 23, 2026Break
It was reported that during a Total hip replacement (THR), while impacting the Pinnacle cup, the end of the impactor sheared off. The device was removed from the surgical field and the offset impactor was utilized instead. There was no reported patient or user harm. There was no significant delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869700 ↗MalfunctionSep 22, 2026Break
Hit cap/rear part of the instrument completely broken off again, is now very common.Have patients or users been harmed? Unknown.Was there a significant delay? Unknown.
Patient problems: Insufficient Information
MAUDE report 50853559 ↗MalfunctionSep 22, 2026Break
Hit cap/rear part of the instrument completely broken off again.Have patients or users been harmed? Unknown.Was there a significant delay? Unknown.
Patient problems: Insufficient Information
MAUDE report 50853513 ↗MalfunctionSep 22, 2026Break
Hit cap/rear part of the instrument completely broken off again, is now very common. Have patients or users been harmed? Unknown. Was there a significant delay? Unknown.
Patient problems: Insufficient Information
MAUDE report 50853396 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848656 ↗MalfunctionSep 21, 2026Break
It was reported that during a Total Hip Replacement surgery the pinnacle straight screwdriver stripped and the pinnacle cup impactor end piece broke off. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840308 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828386 ↗MalfunctionSep 18, 2026Break
It was reported that the back part of the acetabular impactor broke into two pieces during impaction with a hammer at the surgery. No patient or user harm was reported. There was no significant delay. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820343 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785603 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777849 ↗MalfunctionSep 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762500 ↗MalfunctionSep 2, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554842 ↗MalfunctionAug 18, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50308135 ↗
Other IMPACTOR devices
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
- SELF CENTERING 2055-13-000Depuy (Ireland) · IMPACTOR324 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.
How reports and recalls are matched · Editorial policy · Report an error on this page