MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DISCOVERY ELBOW; DISC ULNA BEARING KIT

Catalog Number 114800

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 11/21/2016

Event Type  Injury  

Event Description

Revision surgery - the patient had a revison 7 years ago and they put in a segmental revision system (srs) distal humeral replacement; this surgery was required due to a worn poly bushing.

Manufacturer Narrative

The concomitant part was reported as the main part number on the initial medical device report.Manufacturer narrative: the reason for this revision surgery was a worn poly bushing.The actual length of patient in-vivo service for this product is unknown as the original surgery date was not provided or could be established.The complaint, however: does indicate the implants may have been in use as much as seven 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.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 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 reported they have no additional information to report for this evaluation.This event is deemed to be non-product related.The root cause for poly bushing wear was not reported.The surgeon reported no issues associated with the explanted product.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions, root cause, relating to this event could not be determined with confidence.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 BEARING KIT
• 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: 6194920
• MDR Text Key: 62998523
• Report Number: 1644408-2016-00986
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912224833
• UDI-Public: (01)00888912224833
• 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: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2017
• 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: 114800
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR