MAUDE Adverse Event Report: ARTHROSURFACE HEMICAP TOE IMPLANT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Disability (2371); Inadequate Pain Relief (2388); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/08/2013

Event Type  Injury  

Event Description

Arthrosurface hemicap toe implant was placed in my right foot.It has caused more pain and less function than pre op.I have spent hundreds of dollars on f/u appointments and physical therapy that hasn't worked.I am unable to resume my previous active lifestyle and can't perform my job as well.I am scheduled to have this removed and have the toe rebuilt and fused at more expense to me.These implants should be taken off the market.Their success rate is dismal.

• Brand Name: HEMICAP TOE IMPLANT
• Type of Device: HEMICAP TOE IMPLANT
• Manufacturer (Section D): ARTHROSURFACE
• MDR Report Key: 4749732
• MDR Text Key: 5886243
• Report Number: MW5042492
• Device Sequence Number: 1
• Product Code: LZJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Treatment: CELEBREX,; OTC MEDS: TYLENOL,; RX MEDS: LISINOPRIL,; IBUPROFEN.; PRAVASTATIN,; FLONASE,
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 70