Wright Medical voluntarily recalled CONSERVE hip system due to metal particle shedding
[RECALL]Sep 20, 2004 · Investigated by FDA · Wright Medical Group
Failure Mode
RECALL
Event Date
Sep 20, 2004
Primary Entity
Investigated by FDA
Robotic Platform
Wright Medical Group
Jurisdiction / Location
Federal / Global
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
On September 20, 2004, Wright Medical Group voluntarily recalled its CONSERVE hip system after the metal-on-metal implant proved prone to shedding metal particles into the body, causing tissue damage, pain, and early implant failure. A 2016 study found an 18.4% revision rate within 4.5 years, well above acceptable norms. The company faced numerous lawsuits and eventually exited the hip implant business in 2016.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://gravesmclain.com/practice-areas/wright-medical-recalls-hip-replacement-units/
https://gravesmclain.com/practice-areas/wright-medical-recalls-hip-replacement-units/
- Inspect Filing
https://www.drugwatch.com/hip-replacement/wright-medical/
https://www.drugwatch.com/hip-replacement/wright-medical/
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Details
Incident Context & FAQ
What happened in Wright Medical voluntarily recalled CONSERVE hip system due to metal particle shedding?
On September 20, 2004, Wright Medical Group voluntarily recalled its CONSERVE hip system after the metal-on-metal implant proved prone to shedding metal particles into the body, causing tissue damage, pain, and early implant failure. A 2016 study found an 18.4% revision rate within 4.5 years, well above acceptable norms. The company faced numerous lawsuits and eventually exited the hip implant business in 2016.
When did this incident occur?
The incident is recorded as occurring on September 20, 2004 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Wright Medical voluntarily recalled CONSERVE hip system due to metal particle shedding?
The incident is recorded as involving Wright Medical Group on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Wright Medical voluntarily recalled CONSERVE hip system due to metal particle shedding?
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 Wright Medical voluntarily recalled CONSERVE hip system due to metal particle shedding?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.