MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FOUNDATION HIP METAL-ON-METAL LINER - NEUTRAL MP9

Catalog Number 499-38-009

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/22/2012

Event Type  Other  

Manufacturer Narrative

On (b)(6), 2010 an agent reported a revision surgery. The doctor suggested the reason for the surgery may be due to possible metallosis. The original surgery was performed on or about (b)(6), 2010 meaning the components had been implanted approximately 2. 5 years at the time of the revision. The outcomes attributed to the event are required intervention to prevent permanent impairment/damage. There was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended. The device was not returned to djo surgical for examination. A review of the device history records showed no non-conforming material reports associated with this product. All released components met critical dimensions and specifications. A review of the product complaint report history shows there are 19 prior complaints against the part number 499-38-009 metal-on-metal liner. This is the first complaint of metallosis for this part number and the first complaint for this lot number. The complaints include: four involving infection, three for osteolysis and general pain, two for dislocation issues, two for liner displacement, one for a squeaky hip, one loose stem, one metal hypersensitivity, one liner wear, and one for trauma. The root cause for the revision surgery is listed as possible metallosis. Because the components were not returned, a definitive root cause cannot be determined. Metallosis is a complication of total joint replacement that triggering an adverse reaction in the surrounding tissue and is caused by metal wear which introduces loose metal material into the joint area. All components have been shown to have met all critical specifications when released from djo surgical and there has been no evidence presented that suggests a product design or manufacturing problem contributed to the revision.

Event Description

Revision surgery - possible metallosis.

• Brand Name: FOUNDATION HIP
• Type of Device: METAL-ON-METAL LINER - NEUTRAL MP9
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd; austin TX 78758 544
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, TX 78758 ; 5128346255
• MDR Report Key: 2724937
• MDR Text Key: 21893579
• Report Number: 1644408-2012-00471
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/23/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2012
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2013
• Device Catalogue Number: 499-38-009
• Device Lot Number: 53942728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/30/2012 Patient Sequence Number: 1

Treatment

411-00-000, LOT 54064701; 497-38-000, LOT 53993342