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

Catalog Number 114904

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 01/12/2018

Event Type  Injury  

Event Description

Revision surgery - due to a loose humeral component and pain.

Manufacturer Narrative

The reason for this revision surgery was due to a loose humeral component.The original surgery date was not provided or could be established, therefore the length of in-vivo cannot be determined.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.This complaint evaluation is limited in scope since the part associated with this investigation was not returned to djo surgical for evaluation.No information submitted with the complaint that would indicate a material, design, or manufacturing issue with the explanted part.A review of the device history record (dhr) was not conducted since an item and or lot number was not provided or determined during the complaint evaluation.No additional information was obtained to assist in the event identification.As of 26-feb-2018, no records have been forwarded by zimmer-biomet concerning this event.Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review will be conducted.The root cause of this complaint was a revision surgery due to loose humeral component.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.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: 7206055
• MDR Text Key: 97765520
• Report Number: 1644408-2018-00057
• 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: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2018
• 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 Sequence Number: 1
• Treatment: 114826
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR