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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FMP HIP LINER/NON-HOODED-NEU, MP10, HXE-PLUS, 44MM

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ENCORE MEDICAL, L.P. FMP HIP LINER/NON-HOODED-NEU, MP10, HXE-PLUS, 44MM Back to Search Results
Catalog Number 931-44-760
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 03/04/2016
Event Type  Injury  
Event Description

Revision surgery - due to the patient dislocating.

 
Manufacturer Narrative

The reason for this revision surgery was hip dislocation. The length of the in-vivo service was 2. 4 months. 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 a serious risk to the patient. 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 (b)(4) for examination. A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing history of this part. All parts were found to meet design and manufacturing specifications. No non-conforming material reports (ncmr's) were associated with this part. The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review. This event is deemed to be non-product related. The surgeon reported no issues associated with the explanted product and provided no information that definitively described the root cause or reason of the dislocation. The scope of this investigation is limited without having the parts available to (b)(4)for evaluation. Other conditions relating to this event could not be determined with confidence. Factors that may contribute to a dislocation not associated with the implant are: improper implant selection, degenerative bone disease, and improper surgical technique. Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

 
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Brand NameFMP HIP
Type of DeviceLINER/NON-HOODED-NEU, MP10, HXE-PLUS, 44MM
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 Key5531713
MDR Text Key41366235
Report Number1644408-2016-00219
Device Sequence Number1
Product Code OQH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device Catalogue Number931-44-760
Device LOT Number764N1002
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/23/2014
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: 03/29/2016 Patient Sequence Number: 1
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