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 No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2019

Event Type  Injury  

Event Description

Revision surgery - due to loosening on humeral side.

Manufacturer Narrative

The reason for this revision surgery was due to humeral loosening.The actual length of in-vivo for the item(s) listed is unknown as the original surgery date was not provided or could be established.The healthcare professional indicated there was a 15-20 minute 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 records (dhr) was not conducted since the lot number was not provided or determined during the complaint evaluation.Customer complaint history of the reported device(s) showed no present trends or on-going issues that are in need of review.Given the limited information, a search of djo records for an invoice of the previous surgery produced no results.Because of the acquisition by djo surgical, an extended search of zimmer biomet records cannot be conducted.Any records before the acquisition date, that have not been forwarded, will not be made available.The root cause of this complaint was a revision surgery due to humeral loosening.There are no indications of a product or process issue affecting implant safety or effectiveness.The surgeon performed this procedure to remedy the patient's condition.This complaint will be closed with the lot number(s) unknown.Should additional information become available at a later date, the complaint will be updated.

• 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
• MDR Report Key: 8442503
• MDR Text Key: 139534079
• Report Number: 1644408-2019-00216
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225465
• UDI-Public: (01)00888912225465
• Combination Product (y/n): N
• PMA/PMN Number: K013042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• 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
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114700; 114700
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR