System 12 6302-5-062Recalls & reported problems
Howmedica Osteonics Corp. · 0degrees Polyethylene Insert · Class 2 · Implant
All models of System 12 (8)
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 04546540269652), received between Nov 3, 2021 and Nov 3, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Naturally Worn” (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 16, 2026.
Most reported problems
Device problems
- Naturally Worn1
- Unstable1
Patient problems
- Joint Laxity1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 3, 2021Unstable; Naturally Worn; Unstable; Naturally Worn
IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO ECCENTRIC WEAR OF THE POLY LINER AND INSTABILITY. A HEAD AND LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Laxity
MAUDE report 12749825 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous devices
- Accolade 6021-0537Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous46 reports
- PROFEMUR® PHAC1252Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous37 reports
- Accolade 6020-0335Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous35 reports
- OXINIUM 71342340Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous32 reports
- EXETER 0580-1-351Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous29 reports
- INSTRUMENT 2101-0200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous27 reports
- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
- Accolade 6720-0330Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 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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