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U.S. Department of Health and Human Services

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

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ENCORE MEDICAL, L.P. FOUNDATION HIP METAL-ON-METAL LINER - NEUTRAL MP9 Back to Search Results
Catalog Number 499-38-009
Event Date 08/22/2012
Event Type  Other  
Event Description

Revision surgery - possible metallosis.

 
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.

 
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Brand NameFOUNDATION HIP
Type of DeviceMETAL-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 Key2724937
Report Number1644408-2012-00471
Device Sequence Number1
Product CodeKWA
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 Received08/30/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2013
Device Catalogue Number499-38-009
Device LOT Number53942728
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/23/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/18/2008
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
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