MAUDE Adverse Event Report: ENCORE - DJO SURGICAL ENCORE MEDICAL METAL ON METAL HIP PROSTHETIC HIP

Model Number METAL ON METAL ENCORE

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Type  Other  

Event Description

Swelling pain, and decreased mobility with increased blood serum cobalt. Since total hip replacement (2004 pt. (b)(6)) with encore (now djo surgical) metal on metal hip, have had increasing pain, and swelling requiring occasional narcotic pain control medications. Continued and frequent pain and swelling at this point, elevated serum cobalt 10. 3.

• Brand Name: ENCORE MEDICAL METAL ON METAL HIP
• Type of Device: PROSTHETIC HIP
• Manufacturer (Section D): ENCORE - DJO SURGICAL
• MDR Report Key: 2296530
• MDR Text Key: 2214207
• Report Number: MW5022605
• Device Sequence Number: 1
• Product Code: KWA

Combination Product (Y/N)

• 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: 10/10/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/10/2011
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: METAL ON METAL ENCORE
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Patient TREATMENT DATA

Date Received: 10/10/2011 Patient Sequence Number: 1