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

Catalog Number 114904

Device Problems Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 06/10/2016

Event Type  Injury  

Event Description

Revision surgery - due to the humeral component loosening, and a fracture on the humerus.

Manufacturer Narrative

The reason for this revision surgery was device loosening and a fracture on the humerus.The length of in-vivo service is unknown since the original surgery date was not provided with the complaint and could not be established.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 a lot number was not provided or could be determined.Multiple searches of the djo surgical records and patient database produced no additional information concerning this event.The complaint investigation history records were reviewed and no trends or on-going issues were deemed as present or in need of review.This complaint is non-product related.The complaint states the patient's humeral component was loosening and there was a fracture on the humerus after an unspecified length of in-vivo service.The root cause relating to this event was not reported and could not be determined with confidence.The surgeon reported no issues associated with the explanted product.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 4X100MM LT FLANGED C
• 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: 5778950
• MDR Text Key: 49067613
• Report Number: 1644408-2016-00442
• 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: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2016
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR