Zimmer ROSA Recon: reaming produced an oblong hole requiring a bone graft (FDA MAUDE)
[INJURY]Jun 24, 2024 · Zimmer Biomet · ROSA · France
Failure Mode
INJURY
Event Date
Jun 24, 2024
Primary Entity
Zimmer Biomet
Robotic Platform
ROSA
Jurisdiction / Location
France
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
An FDA MAUDE injury report describes a Zimmer ROSA Recon case in which reaming resulted in an oblong hole due to hard bone, and the surgeon grafted the defect. Source: FDA MAUDE MDR key 24316286, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
- Inspect Filing
https://www.zimmerbiomet.com/
https://www.zimmerbiomet.com/
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=24316286&pc=OLO
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=24316286&pc=OLO
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Details
Incident Context & FAQ
What happened in Zimmer ROSA Recon: reaming produced an oblong hole requiring a bone graft (FDA MAUDE)?
An FDA MAUDE injury report describes a Zimmer ROSA Recon case in which reaming resulted in an oblong hole due to hard bone, and the surgeon grafted the defect. Source: FDA MAUDE MDR key 24316286, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
When did this incident occur?
The incident is recorded as occurring on June 24, 2024 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Zimmer ROSA Recon: reaming produced an oblong hole requiring a bone graft (FDA MAUDE)?
ROSA by Zimmer Biomet is the recorded robot involved in this incident at France.
Has anyone responded to Zimmer ROSA Recon: reaming produced an oblong hole requiring a bone graft (FDA MAUDE)?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Zimmer ROSA Recon: reaming produced an oblong hole requiring a bone graft (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.