PINNACLE 2217-50-044Recalls & reported problems
Depuy (Ireland) · PINNACLE INCLINATION/VERSION GUIDE · Class 1
All models of PINNACLE (198)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle version guide is a small alignment tool used during hip replacement surgery to position the implant cup. The 27 reports describe wear and damage over time: bent or cracked guides, worn threads, missing pieces, and guides that no longer fit the cup impactor. Most mention no effect on the patient. There have been no deaths or injuries, and 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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295098997), received between Nov 9, 2018 and Feb 3, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility9
- Material Deformation9
- Detachment of Device or Device Component7
- Break5
- Crack4
- Mechanical Jam1
- Naturally Worn1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information5
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2026Crack; Material Deformation
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED WITH WEAR AND TEAR OVER TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24246629 ↗MalfunctionFeb 3, 2026Crack; Material Deformation
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED WITH WEAR AND TEAR OVER TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24246619 ↗MalfunctionFeb 3, 2026Crack; Material Deformation
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED WITH WEAR AND TEAR OVER TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24246610 ↗MalfunctionFeb 3, 2026Crack; Material Deformation
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED WITH WEAR AND TEAR OVER TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24246602 ↗MalfunctionDec 12, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE VERSION GUIDE WAS DAMAGED. THE END IS BENT AND WILL NO LONGER GO INTO THE CUP IMPACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23794831 ↗MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS IDENTIFIED DURING LOAN KIT INSPECTION THAT THE VERSION GUIDE HAS 2 PARTS, THIS ONE IS MISSING ONE HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22641750 ↗MalfunctionMay 2, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT ITEMS ARE OLD AND NO LONGER FIT FOR PURPOSE. THREAD ON PINNACLE HANDLE IS WEARING. THE EVENT DIDN'T HAPPEN DURING PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21951121 ↗MalfunctionJan 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS A MISSING PINNACLE VERSION GUIDE. FRAGMENTS WERE MADE BY THE FEMORAL HEAD TRIAL, THEY WERE EASILY REMOVED. THE HEAD TRIAL IS WORN AND NEEDED REPLACING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21216694 ↗MalfunctionNov 19, 2024Break; Break
IT WAS REPORTED THAT THE KNOB ON THE END OF THE HANDLE BROKE OFF. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20722236 ↗MalfunctionOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING LOAN KIT INSPECTION IT WAS IDENTIFIED THAT THE DEVICE IS MISSING A PART. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20569521 ↗MalfunctionAug 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PRODUCT WAS DETECTED TO BE INCOMPLETE DURING INSPECTION.
Patient problems: Insufficient Information
MAUDE report 19980351 ↗MalfunctionJun 5, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE VERSION ROD WAS BENT SO IT WOULDN'T FIT THROUGH HOLES. ITEM WAS DISCARDED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19466451 ↗MalfunctionMar 25, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE VERSION ROD WAS BENT, DISABLING IT FROM GOING IN THE ALIGNMENT ROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18969902 ↗MalfunctionFeb 26, 2024No Apparent Adverse Event; No Apparent Adverse Event
PRODUCT WAS DETECTED TO BE INCOMPLETE DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18785486 ↗MalfunctionAug 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT 1 OF 2 PARTS WAS MISSING. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17623468 ↗MalfunctionAug 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE VERSION GUIDE HAD MISSING COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17550341 ↗MalfunctionJun 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
PRODUCT WAS DETECTED TO BE INCOMPLETE DURING INSPECTION.
Patient problems: Insufficient Information
MAUDE report 17162266 ↗MalfunctionAug 19, 2022Break; Break
IT WAS REPORTED THAT THE VERSION GUIDE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15261883 ↗MalfunctionJul 25, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENTS ON THE PINNACLE INSTRUMENT SET BROKE. NO HARM TO THE PATIENT AND NO DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15094777 ↗MalfunctionFeb 22, 2022Break; Break
IT WAS REPORTED THAT THE PINNACLE IMPACTOR BROKE DURING A CASE. NO DELAY OR ISSUES RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13576705 ↗MalfunctionFeb 8, 2022Mechanical Jam; Mechanical Jam
SCREW IS CAUSING ALIGNMENT ISSUE WITH THE ROD AND THE GUIDE. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13484802 ↗MalfunctionJan 7, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
THE SCREW HAS BEEN TURNED INWARDS AND THE PIN CANNOT BE PUT IN PLACE. THE SURGEON COMPLETED THE PROCEDURE WITH A SLIGHT DELAY AND WITHOUT COMPLICATIONS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13190881 ↗MalfunctionDec 29, 2021Break; Break
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SCREW THAT WAS MENTIONED WAS PART OF THE REPORTED INSTRUMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13108966 ↗MalfunctionMar 1, 2021Device-Device Incompatibility; Device-Device Incompatibility
SURGEON REPORTED THAT THE THROUGH-ROD OF PINNACLE ALIGNMENT GUIDE WAS TOO SMALL FOR THE HOLE INSIDE THE UP-ROD CAUSING IT TO POTENTIALLY FALL OUT AS IT IS TOO LOOSE. HE WANTED IT REPLACED INCASE IT FELL ON THE FLOOR AND BECAME UN-STERILE. SURGERY WAS NOT DELAYED. PROCEDURE SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11391984 ↗MalfunctionDec 13, 2019Break; Break
SURGEON WAS USING THE SHELL IMPACTOR HANDLE WITH THE 36MM HEAD ATTACHMENT TO SEAT THE LINER IMPLANT INTO THE SHELL, AND THE BACK END OF THE IMPACTOR HANDLE SHEARED OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9469151 ↗
Other WRENCH devices
- MONARCH 277040510Medos International Sàrl · WRENCH199 reports
- PINNACLE 2217-50-008Depuy (Ireland) · WRENCH108 reports
- SIGMA 96-1673Depuy (Ireland) · WRENCH102 reports
- P.F.C. 86-5189Depuy (Ireland) · WRENCH92 reports
- Veptr 03.641.004Synthes GmbH · WRENCH86 reports
- RECLAIM 2975-00-300Depuy (Ireland) · WRENCH51 reports
- PINNACLE 2217-50-006Depuy (Ireland) · WRENCH34 reports
- NA 388.261Synthes GmbH · WRENCH32 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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