InSitu Hip System 10-32-0062Recalls & reported problems

Nextstep Arthropedix, LLC · Acetabular Cup, Size 62, Holed, Anodized · Class 2 · Implant

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816127022647), received between Oct 17, 2025 and Oct 17, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Corroded” (1 report).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Corroded1

Patient problems

Arthralgia1
Metal Related Pathology1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryOct 17, 2025Corroded; Corroded
IT WAS REPORTED THAT A COCR FEMORAL HEAD AND ACETABULAR LINER WERE REVISED IN A PATIENT THAT PRESENTED WITH PAIN.
Patient problems: Arthralgia; Metal Related Pathology
MAUDE report 23329364 ↗

Device details

UDI-DI	`00816127022647`
Brand	InSitu Hip System
Model	10-32-0062
Company	Nextstep Arthropedix, LLC
Product code	OQI · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Class	Class 2
FDA submission	K161184
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 9, 2020

Device type (GMDN): Acetabular shell

An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Other Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented devices

AcuMatch 142-32-27
Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
2 recalls0 reports
Novation 140-36-52
Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
1 recall8 reports
G7 DEPTH GAUGE 110010717
Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
54 reports
Novation 140-32-52
Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
1 recall2 reports
Novation 142-32-61
Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
1 recall1 report
Novation 140-36-54
Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
1 recall1 report
Novation 142-28-52
Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
1 recall0 reports
Novation 148-32-51
Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
1 recall0 reports

All Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented 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.

How reports and recalls are matched · Editorial policy · Report an error on this page