MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. EPIK KNEE; EPIK UNI FEMUR 10 L MEDIAL/R LATERAL

Catalog Number 200-01-110

Device Problems Device Operates Differently Than Expected (2913); Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 07/08/2014

Event Type  Injury  

Event Description

Revision surgery - due to the patient experiencing a lot of pain; the surgeon removed the epik implants.The surgeon noted that the polyethylene in the insert had worn through.

Manufacturer Narrative

The reason for this revision surgery was identified as pain after 9.7 years of patient use.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records showed no non-conforming material reports associated with this product.A review of the product complaint report history showed this is the first complaint for a product from this lot.The root cause for the patients pain was reported as a worn out insert ; most likely the insert wear was due to normal use over time.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: EPIK KNEE
• Type of Device: EPIK UNI FEMUR 10 L MEDIAL/R LATERAL
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 3932214
• MDR Text Key: 4575869
• Report Number: 1644408-2014-00443
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2009
• Device Catalogue Number: 200-01-110
• Device Lot Number: 768471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(4), LOT 767181; (B)(4), LOT 768321
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR