MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 5X150MM RT FLANGED C

Catalog Number 114917

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 09/27/2017

Event Type  Injury  

Event Description

Revision surgery - due to the patient's humeral loosening; the stem because loose on the humeral side.

Manufacturer Narrative

The reason for this revision surgery was due to the patient's humeral loosening.The actual length of in-vivo patient service for this product is unknown as the original surgery date was not provided or could be established.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.A review of the device history records and product complaint report history for this product could not be conducted due to no part or lot number being reported.This complaint is deemed to be non-product related.The complaint states the patient had a loosened humeral stem.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions, root cause, relating to this event could not be determined with confidence.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC HUM 5X150MM RT 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: 6980039
• MDR Text Key: 90333135
• Report Number: 1644408-2017-00909
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225571
• UDI-Public: (01)00888912225571
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR