NA 802804003Recalls & reported problems

Zimmer, Inc. · Class 2 · Implant

Data updated Oct 16, 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 00887868376696), received between Aug 5, 2025 and Aug 5, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K181171); they may or may not involve this specific model.

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

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

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Detachment of Device or Device Component1
Fracture1

Patient problems

Medical device site infection1
Necrosis1
Pain1
Scar Tissue1

Recent adverse event reports

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

InjuryAug 5, 2025Fracture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Fracture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY ONE AND A HALF YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INFECTION, PAIN, INFLAMMATION, AND HEAD AND TRUNNION DISASSOCIATION DEMONSTRATED ON X-RAYS. DURING THE REVISION THE HEAD WAS CONFIRMED FRACTURED, THERE WAS SIGNIFICANT SCAR TISSUE, AND NECROTIC TISSUE WAS DEBRIDED FROM THE CUP. ALL COMPONENTS REVISED AND A CEMENT SPACER IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Medical device site infection; Necrosis; Pain; Scar Tissue
MAUDE report 22722618 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181171. One submission often covers many models, so check the product and lot details in each record.

Z-1647-2025 · Mar 24, 2025 · Open, Classified
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Z-1646-2025 · Mar 24, 2025 · Open, Classified
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncem
Z-1649-2025 · Mar 24, 2025 · Open, Classified
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Z-1648-2025 · Mar 24, 2025 · Open, Classified
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Z-1645-2025 · Mar 24, 2025 · Open, Classified
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncem

Device details

UDI-DI	`00887868376696`
Brand	NA
Model	802804003
Company	Zimmer, Inc.
Product code	KWY · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Class	Class 2
FDA submission	K181171
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): Ceramic femoral head prosthesis

An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices

STAGEONE 431209
Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
2 recalls0 reports
SELF CENTERING 1035-45-000
Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
84 reports
LFIT 6260-9-036
Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
80 reports
ACTIS 101011060
Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
66 reports
RINGLOC BI-POLAR HIP SYSTEM 11-165228
Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
1 recall1 death12 reports
SELF CENTERING 1035-44-000
Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
60 reports
TANDEM 71324046
Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
1 recall9 reports
TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170
Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
59 reports

All Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or 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 16, 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