MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 4X75MM LT W BRNG C

Catalog Number 114822

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/19/2017

Event Type  Injury  

Event Description

Revision surgery - the surgeon found that the ulna component broke and needed a revision done.The agent was told that the patient had elbow surgery at a young age (over 20 years ago) and also has hemophilia and over time from different falls may have made the part malfunction.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery wast he surgeon found that the ulna component broke and needed a revision.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.The healthcare professional indicated there was a serious risk 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 and part number was not provided or determined during the complaint evaluation.The implant in-vivo service length is unknown without an original surgery date.Multiple searches of the djo surgical records by surgeon and patient database revealed no additional information concerning this event.Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review shall be conducted.This complaint will be closed with the lot and part number unknown pending receipt of additional information.No further action is deemed necessary at this time.This complaint is deemed to be non-product related.The complaint states the surgeon found that the ulna component broke and needed a revision done.Agent was told that the patient had elbow surgery at a young age (over 20 years ago) and also has hemophilia and over time from different falls may have made the part malfunction.This revision was necessary to correct the patient's condition.No other conditions relating to this event could be determined with confidence.The surgery was completed as intended and without incident.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 ULNA 4X75MM LT 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: 6803940
• MDR Text Key: 83023107
• Report Number: 1644408-2017-00678
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225205
• UDI-Public: (01)00888912225205
• 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: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 09/01/2017
• Supplement Dates FDA Received: 09/29/2017
• 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): Other; Required Intervention
• Patient Age: 42 YR