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

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.

• 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 Key: 5932623
• MDR Text Key: 54064965
• Report Number: 1644408-2016-00621
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912224833
• UDI-Public: (01)00888912224833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051975
• Number of Events Reported: 1
• 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 Number: 114700
• Device Lot Number: 172870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention