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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. METAL/METAL HIP LINER, METAL-METAL 34MM NEUTRAL MP7

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ENCORE MEDICAL L.P. METAL/METAL HIP LINER, METAL-METAL 34MM NEUTRAL MP7 Back to Search Results
Catalog Number 499-34-007
Device Problem Insufficient Information (3190)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/21/2022
Event Type  Injury  
Event Description
Revision surgery - the patient needed to be revised.
 
Manufacturer Narrative
The reason for this revision surgery was reported as patient needed to be revised. The previous surgery and the surgery detailed in this event occurred 13 years apart. Initial or prolonged hospitalization was 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 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 due to patient needed to be revised. 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. There are multiple factors that may also contribute to an event that are outside the control of djo surgical. There are no indications of a product or process issue affecting implant safety or effectiveness. Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
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Brand NameMETAL/METAL HIP
Type of DeviceLINER, METAL-METAL 34MM NEUTRAL MP7
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
james mcmahon
9800 metric blvd
austin, tx 78758-5445 
MDR Report Key14016597
MDR Text Key288664238
Report Number1644408-2022-00435
Device Sequence Number1
Product Code KWA
UDI-Device Identifier00888912087742
UDI-Public(01)00888912087742
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040354
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2013
Device Catalogue Number499-34-007
Device Lot Number53936330
Was Device Available for Evaluation? No
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/04/2008
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: 04/05/2022 Patient Sequence Number: 1
Treatment
411-00-000 LOT 53970175; 497-34-000 LOT 53932116
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