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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. 3DKNEE INSERT, 3D EX SZ 10LT 13MM

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ENCORE MEDICAL, L.P. 3DKNEE INSERT, 3D EX SZ 10LT 13MM Back to Search Results
Catalog Number 391-13-710
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 01/16/2017
Event Type  Injury  
Event Description
Revision surgery - the poly was swapped out due to minor infection.
 
Manufacturer Narrative
Corrected data: expiration date should be 28 sep 2018. Manufacturer narrative: the reason for this revision surgery was an infection. The previous surgery and the revision detailed in this investigation occurred 28 days apart. 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 possible infection or inhibited the patient's immune system. 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 device was disposed of at the hospital and not made available to djo surgical for examination. A review of the implant device history records (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to an infection. The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery. There were no findings during this investigation that indicate that the reported device was the root cause or had a direct connection with the patient's infection. Due to the short time between the original surgery and the revision, it is possible that the infection was acquired in the hospital (nosocomial). It is also possible that the patient was not compliant with post surgical instructions. There are multiple factors that may contribute to an infection that are outside of the control of djo surgical. There are no indications of a product or process issue affecting implant safety or effectiveness.
 
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Brand Name3DKNEE
Type of DeviceINSERT, 3D EX SZ 10LT 13MM
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 5445
Manufacturer Contact
teffany hutto
9800 metric blvd.
austin, TX 78758-5445
5128346255
MDR Report Key6314287
MDR Text Key66918024
Report Number1644408-2017-00057
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912119535
UDI-Public(01)00888912119535
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091956
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 03/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2018
Device Catalogue Number391-13-710
Device Lot Number59604057
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 Received02/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/02/2013
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: 02/09/2017 Patient Sequence Number: 1
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