MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA 3X75MM RT W BRNG C

Catalog Number 114813

Device Problem Contamination (1120)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was due to an infection. The previous surgery and the revision detailed in this investigation occurred 22 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 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 device history record (dhr) and the verification of acceptable sterilization process could not conducted as the records needed for review were not provided during this complaint evaluation. As of 9-feb-2018, no records have been forwarded by zimmer-biomet. Should the records be provided at a later time, this investigation will be updated or amended. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. 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.

Event Description

Revision surgery - due to an infection. The surgeon removed and replaced the poly from the ulna component and the humeral condyle kit.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 3X75MM RT W BRNG C
• 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: teffany hutto ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 7150899
• MDR Text Key: 273868198
• Report Number: 1644408-2017-01225
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 114813
• Device Lot Number: 691100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 12/28/2017 Patient Sequence Number: 1

Treatment

114700, LOT 216390