INSTRUMENT I-H2022AG00Recalls & reported problems

Howmedica Osteonics Corp. · SPECIALTY TRIDENT TRITANIUM ALIGNMENT GUIDE · Class 2

All models of INSTRUMENT (131)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327347524), received between Jul 18, 2019 and Jul 18, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (2 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.

Most reported problems

Device problems

Device Misassembled During Manufacturing /Shipping2

Patient problems

No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 18, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
AFTER RECEIVING TWO CUSTOM MADE INSTRUMENTS, WE REMOVED THEM FROM THE PACKAGING AND REVIEWED THE INSTRUMENT BEFORE SHOWING THE PHYSICIAN. WHEN PUTTING THE GUIDE ON THE INSERTER WE NOTICED SOMETHING DID NOT SEEM CORRECT. I HAD CONTACTED THE REP FROM THE CUSTOMS INSTRUMENTS DECISION AND SENT PICTURES TO SEE IF SOMETHING WAS DONE INCORRECTLY. AFTER SENDING PICTURES AND THE PRODUCT NUMBER STEPHEN NOTICED THAT THE PIN ON THE MODULAR SLEEVE IS PROTRUDING OUT THE WRONG SIDE ROTATING EVERYTHING 180 DEGREES IN THE WRONG DIRECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8803353 ↗
MalfunctionJul 18, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
AFTER RECEIVING TWO CUSTOM MADE INSTRUMENTS, WE REMOVED THEM FROM THE PACKAGING AND REVIEWED THE INSTRUMENT BEFORE SHOWING THE PHYSICIAN. WHEN PUTTING THE GUIDE ON THE INSERTER WE NOTICED SOMETHING DID NOT SEEM CORRECT. I HAD CONTACTED THE REP FROM THE CUSTOMS INSTRUMENTS DECISION AND SENT PICTURES TO SEE IF SOMETHING WAS DONE INCORRECTLY. AFTER SENDING PICTURES AND THE PRODUCT NUMBER STEPHEN NOTICED THAT THE PIN ON THE MODULAR SLEEVE IS PROTRUDING OUT THE WRONG SIDE ROTATING EVERYTHING 180 DEGREES IN THE WRONG DIRECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8803337 ↗

Device details

UDI-DI	`07613327347524`
Brand	INSTRUMENT
Model	I-H2022AG00
Company	Howmedica Osteonics Corp.
Product code	JDI · Prosthesis, hip, semi-constrained, metal/polymer, cemented
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 3, 2023

Device type (GMDN): Orthopaedic prosthesis implantation positioning instrument, reusable

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

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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