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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. X-ALT HIP LINER 10 DEG HOODED-NEU, MP9, HXE-PLUS, 40MM

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ENCORE MEDICAL L.P. X-ALT HIP LINER 10 DEG HOODED-NEU, MP9, HXE-PLUS, 40MM Back to Search Results
Model Number 932-40-756
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Failure of Implant (1924)
Event Date 09/18/2019
Event Type  Injury  
Manufacturer Narrative

The reason for this revision surgery was reported as loosening. The previous surgery and the surgery detailed in this event occurred 1 day apart. Initial or prolonged hospitalization is required. 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 devices were disposed of at the hospital and not made available to djo surgical for examination. A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements. There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event. The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery. Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review. The root cause of this complaint was a revision surgery loosening. There were no findings during this evaluation that indicate the reported devices were defective. No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event. Due to short time between the previous and revision surgery it seems that the event may be occurred due to improper surgical techniques, patient noncompliance with medical instruction or lack of post-operative care. There are no indications of a product or process issue affecting implant safety or effectiveness.

 
Event Description

Revision surgery - due to loose liner.

 
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Brand NameX-ALT HIP
Type of DeviceLINER 10 DEG HOODED-NEU, MP9, HXE-PLUS, 40MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, tx 78758-5445 
MDR Report Key9197682
MDR Text Key162551051
Report Number1644408-2019-01004
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
Report Date 10/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number932-40-756
Device Catalogue Number932-40-756
Device LOT Number815N2010
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/19/2019
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: 10/16/2019 Patient Sequence Number: 1
Treatment
400-03-402 LOT 871B1178
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