MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FOUNDATION HIP; MODULAR BIPOLAR SHELL 44

Catalog Number 412-02-044

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 12/17/2014

Event Type  Injury  

Event Description

Revision surgery - the shell was not sitting correctly due to cement in between the acetabular liner and shell.During the original surgery the surgeon did not clean out the cement properly or do an x-ray during the primary case.

Manufacturer Narrative

The revision surgery was due to the shell not seating properly after 2 days in-vivo.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 the main contributor component listed in the complaint.A review of the product complaint report history showed this is the first complaint for a part from this lot.The root cause for the shell not seating properly was reported as left over cement from the previous surgery due to the surgical technique not being followed properly.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION HIP
• Type of Device: MODULAR BIPOLAR SHELL 44
• 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: 4399377
• MDR Text Key: 5304454
• Report Number: 1644408-2014-00833
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2019
• Device Catalogue Number: 412-02-044
• Device Lot Number: 988B1097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR