MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 6X150MM RT FLANGED C

Catalog Number 114919

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Osteolysis (2377)

Event Date 08/10/2018

Event Type  Injury  

Event Description

Revision surgery - due to bone loss and possible infection.

Manufacturer Narrative

The reason for this revision surgery was due to bone loss and possible infection.The length of in-vivo service could not be determined since the date of the original surgery is unknown.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was a significant adverse event to the patient.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 device history record (dhr) was not conducted since the part and lot number were not provided or determined during the complaint evaluation.No additional information was obtained to assist in the event identification.Given the limited information, an extensive search for an invoice, of the previous surgery, produced no results.Without this information, this investigation is limited in scope.If additional information can be provided at a later time and produces a search with positive results, this investigation will be updated.The root cause of this complaint was a revision surgery due to bone loss and possible infection.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.With the limited information provided about the patient and the devices removed during the revision surgery, it is impossible to determine the source of the infection.Containment based on the information submitted with this complaint it is not possible as the agent was unable to supply the part and lot number.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC HUM 6X150MM RT FLANGED C
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7824405
• MDR Text Key: 118483039
• Report Number: 1644408-2018-00797
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225595
• UDI-Public: (01)00888912225595
• Combination Product (y/n): N
• PMA/PMN Number: K013042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114919
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114700; 114700
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR