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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DISCOVERY ELBOW; DISC CONDYLE KIT W/ HEXALOBULA

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ENCORE MEDICAL, L.P. DISCOVERY ELBOW; DISC CONDYLE KIT W/ HEXALOBULA Back to Search Results
Catalog Number 114700
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Unspecified Infection (1930)
Event Date 08/10/2016
Event Type  Injury  
Event Description
Revision surgery - due to an infection.In (b)(6), the surgeon called and said the patient was infected.They went in and did an irrigation & drainage washout.They removed the condyle kit, left the patient dislocated and gave her antibiotics.The surgeon went back in on (b)(6) 2016, after they deemed the infection had cleared, and replaced the condyle kit referenced on delivery ticket (b)(4).On 29 jul 2016, the representative was notified that the patient was infected again and that the surgeon was going to remove all of the implants.On (b)(6) 2016, the surgeon removed the humeral component, ulna component and condyle kit.
 
Manufacturer Narrative
The reason for this revision surgery was an infection.The previous surgery and the revision detailed in this investigation occurred over 4.7 mos.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 a serious risk to the patient.There was no delay in surgery 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 implant device history records (dhrs) and product complaint report (pcr) database records 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 by biomet (zimmer) inc.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.There are multiple factors that may contribute to an infection that are outside of the control of (b)(4).There are no indications of a product or process issue affecting implant safety or effectiveness.
 
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Brand Name
DISCOVERY ELBOW
Type of Device
DISC CONDYLE KIT W/ HEXALOBULA
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 Key5932623
MDR Text Key54064965
Report Number1644408-2016-00621
Device Sequence Number1
Product Code JDC
UDI-Device Identifier00888912224833
UDI-Public(01)00888912224833
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051975
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number114700
Device Lot Number172870
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/12/2016
Initial Date FDA Received09/07/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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