MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 4X100MM LT FLANGED C

Catalog Number 114904

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 10/07/2017

Event Type  Injury  

Event Description

Revision surgery - due to the revision of total elbow.The humeral component was replaced along with the condyle kit.Uneventful routine revision surgery with no complications.The surgeon was able to address concerns with the new components used during the revision procedure.

Manufacturer Narrative

The reason for this revision surgery was a revision of total elbow.The in-vivo length of patient service for the implant was 1.8 years.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 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.Review of the device history record (dhr) of the explanted part (s) was not conducted as a device history record has not been provided or received at this time.The device history record has been requested from zimmer and when received it will be reviewed.If the review indicates appropriate action should taken the complaint will be re-evaluated to address any issues.This complaint will be closed pending receipt of the device history record.No further action is deemed necessary at this time.The complaint investigation history was reviewed and no trends or on-going issues were deemed to be present or in need of review.No further action is deemed necessary at this time.This event is deemed as non-product related.The root cause for this event was to revise the patient to satisfy the surgeon's concerns.The scope of this investigation is limited without having the explanted parts available to djo surgical for evaluation.Other conditions relating to this event could not be determined with confidence.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC HUM 4X100MM LT FLANGED 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: 7000919
• MDR Text Key: 91012564
• Report Number: 1644408-2017-00976
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225465
• UDI-Public: (01)00888912225465
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114904
• Device Lot Number: 254440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2017
• 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 Sequence Number: 1
• Treatment: 114700,LOT 006670
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR