MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISOVERY ELBOW; DISC HUM 4X150MM LT FLANGED C

Catalog Number 114914

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 03/02/2018

Event Type  Injury  

Event Description

Revision surgery - due to aseptic loosening of the humeral stem.No problem with implant when removed.

Manufacturer Narrative

The reason for this revision surgery was due to aseptic loosening of the humeral stem.The previous surgery and the revision detailed in this investigation occurred 1.1 years apart.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 a significant adverse event 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 item: 114914 device history records (dhr), shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.As of 6-apr-2018, the needed records and the records needed to verify an acceptable sterilization process have not been forwarded by zimmer-biomet.Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated.The root cause of this complaint was a revision surgery due to aseptic loosening of the humeral stem.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: DISOVERY ELBOW
• Type of Device: DISC HUM 4X150MM LT FLANGED C
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7345450
• MDR Text Key: 102624992
• Report Number: 1644408-2018-00226
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225540
• UDI-Public: (01)00888912225540
• 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: 04/09/2018

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: 114914
• Device Lot Number: 241280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/16/2018
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114700, LOT 688620
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR