Z1™ Hip System 611201040Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Z1 Hip System (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868575495), received between Mar 14, 2025 and Sep 8, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (1 report).
1 other recall cover devices cleared under the same FDA submission (K233476, K251906); 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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Positioning Failure1
- Positioning Problem1
Patient problems
- Bone Fracture(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2025Positioning Failure; Positioning Problem; Positioning Failure; Positioning Problem
IT WAS REPORTED THAT THE Z1 STEM WAS DIFFICULT TO POSITION. IT WOULD PERCH AND NOT FULLY SEAT. THE SURGEON NOTED CONCERNS WITH THE PPS COATING, STATING THAT IT WAS TOO THICK AND CAUSED THE STEM TO PERCH. THE STEM WAS EVENTUALLY SEATED, AND THE CASE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22991915 ↗InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Bone Fracture(s)
MAUDE report 21607419 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K233476, K251906. One submission often covers many models, so check the product and lot details in each record.
- Z-1329-2025 · Feb 12, 2025 · Open, ClassifiedZ1 Femoral Hip System, Product Number 611777612
Other Prosthesis, hip, constrained, cemented or uncemented, metal/polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 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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