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

Catalog Number 114823

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 12/01/2016

Event Type  Injury  

Event Description

Revision surgery - due to the surgeon implanted a total elbow in the patient roughly 10 years ago and the ulnar component loosened.

Manufacturer Narrative

The reason for this revision surgery was the ulnar component loosened.The actual length of in-vivo patient service was 8 years.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 record (dhr) was not conducted since a lot number was not provided or determined during the complaint evaluation.A search of the device investigation history produced no anomalies or evidence of a product issue.Multiple searches of the djo surgical records and patient database revealed no additional information concerning this event.Zimmer-biomet was contacted for additional information through an invoice search and they provided an original surgery date but no other information that advanced the complaint evaluation.This complaint will be closed with the lot unknown pending receipt of additional information.Should additional information become available concerning this complaint, the complaint will be re-opened and a further review shall be conducted.This event is deemed to be non-product related.The root cause for the ulnar component loosening was not reported.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions relating to this event 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 ULNA 4X75MM RT W/BRNG 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 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 6201536
• MDR Text Key: 63184693
• Report Number: 1644408-2016-01021
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225212
• UDI-Public: (01)00888912225212
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR