MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FOUNDATION HIP; UNIPOLAR SLEEVE -3.5

Catalog Number 411-00-035

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 06/25/2014

Event Type  Injury  

Event Description

Revision surgery: due to malignment/malposition of the acetabular shell.

Manufacturer Narrative

The reason for this revision surgery was reported as malposition after 3.5 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 1st complaint for this part number.The root cause for the malposition was most likely the acetabular shell being misaligned as reported.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION HIP
• Type of Device: UNIPOLAR SLEEVE -3.5
• 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: 3903373
• MDR Text Key: 4646788
• Report Number: 1644408-2014-00411
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973614
• 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: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 411-00-035
• Device Lot Number: 903B1008
• 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: 08/13/2010
• 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: 497-38-000,LOT A1000001
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR