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

Catalog Number 411-00-035

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 05/20/2015

Event Type  Injury  

Event Description

Revision surgery - due to the femoral stem subsiding, the surgeon removed the original sleeve and head.

Manufacturer Narrative

The reason for this revision surgery was the femoral stem subsided and the original sleeve and head was removed.The length of in vivo service was 1.5 years.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 there have been 12 prior complaints reported against this part number; summary of investigations: 3 for dislocation, 2 for trauma, 1 for infection, 1 for instability and others not associated with product issues.This is the first complaint against this lot number.The surgeon reported no issues associated with the explanted product and provided no information that definitively described the root cause or reason of the subsidence.No other conditions relating to this event could be determined with confidence.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION HIP
• Type of Device: SLEEVE, UNIPOLAR, OFFSET -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: 4802156
• MDR Text Key: 18089544
• Report Number: 1644408-2015-00312
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 411-00-035
• Device Lot Number: 903B1096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2013
• 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: 70 YR