MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 5X100MM RT FLANGED C

Catalog Number 114907

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 12/06/2017

Event Type  Injury  

Event Description

Revision surgery - due to the patient suffering from an ulnar periprosthetic fracture, so a surgical intervention was required to prevent further damage to the patient.The original surgery was several years ago and we were provided very little information prior to the case.

Manufacturer Narrative

The reason for this revision surgery was due to an ulnar periprosthetic fracture.The original surgery date was not provided or could be established, so the in-vivo length of service cannot be determined.The complaint reports no issues of any other patient injuries, activities, accidents that may have been contributory to this surgery.No reported pre-existing patient health conditions.The complaint reported no surgical delays during the revision surgery.The 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 determined during the complaint evaluation.No additional information was obtained to assist in the event identification.As of 2-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 shall be conducted.The root cause of this complaint was a revision surgery due to a ulnar periprosthetic fracture.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 5X100MM 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: 7127420
• MDR Text Key: 95166657
• Report Number: 1644408-2017-01191
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225496
• UDI-Public: (01)00888912225496
• 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: 02/05/2018

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: 114907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 02/02/2018
• Supplement Dates FDA Received: 02/05/2018
• 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: 114700; 114823
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR