NEXGEN® TRABECULAR METAL™ 00-5490-034-10Recalls & reported problems
Zimmer Trabecular Metal Technology Inc. · Class 2 · Implant
All models of NEXGEN TRABECULAR METAL (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024309487), received between Nov 24, 2020 and Nov 24, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Biocompatibility” (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
- Biocompatibility2
Patient problems
- Limited Mobility Of The Implanted Joint2
- Pain2
- Reaction2
- Swelling2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2020Biocompatibility; Biocompatibility
IT WAS REPORTED SHE HAS BEEN ENCOUNTERING PAIN, SWELLING, INFLAMMATION, AND DIFFICULTY WALKING AND EXERCISING SINCE HER REVISION SURGERY. SHE ALSO STATED SHE HAD A METAL ALLERGY TEST DONE, WHICH DETERMINED SHE IS HIGHLY ALLERGIC TO NICKEL AND COBALT CHROMIUM.
Patient problems: Limited Mobility Of The Implanted Joint; Pain; Reaction; Swelling
MAUDE report 10895707 ↗InjuryNov 24, 2020Biocompatibility; Biocompatibility
IT WAS REPORTED SHE HAS BEEN ENCOUNTERING PAIN, SWELLING, INFLAMMATION, AND DIFFICULTY WALKING AND EXERCISING SINCE HER REVISION SURGERY. SHE ALSO STATED SHE HAD A METAL ALLERGY TEST DONE, WHICH DETERMINED SHE IS HIGHLY ALLERGIC TO NICKEL AND COBALT CHROMIUM.
Patient problems: Limited Mobility Of The Implanted Joint; Pain; Reaction; Swelling
MAUDE report 10895559 ↗
Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices
- ATTUNE 1512-14-050Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER106 reports
- ATTUNE 1504-40-205Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall53 reports
- ATTUNE 1504-40-105Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall46 reports
- ATTUNE 1547-06-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall37 reports
- ATTUNE 1513-12-060Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER72 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- ATTUNE 1512-16-080Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall16 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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