MAUDE Adverse Event Report: ENCORE MEDICAL L.P DISCOVER ELBOW; DISC HUM 4X100MM LT FLANGED C

Catalog Number 114904

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Fall (1848)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - patient fell, causing aseptic loosening of humeral component.Humeral and condyle components were removed, a larger humeral component and a new condyle kit were implanted.

Manufacturer Narrative

The reason for this revision surgery was reported as humeral loosening after a fall.The previous surgery and the surgery detailed in this event occurred 1.2 years apart.Initial or prolonged hospitalization was required.The healthcare professional indicated that there was a significant adverse event to patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at the hospital and not made available to djo surgical for examination.For item 540-00-000: a review of implant device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were within its expiration date at the time of the previous surgery.For item 114904: the device history record (dhr) was not found among djo and available zimmer biomet records.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to humeral loosening after a fall.There were no other findings during this evaluation that indicate the reported devices were defective.No other information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: DISCOVER 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: 10801165
• MDR Text Key: 215047043
• Report Number: 1644408-2020-01011
• Device Sequence Number: 1
• Product Code: JDC
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114904
• Device Lot Number: 521300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 540-00-000 LOT 75736.; 600-10-100 LOT 844E1D0018.; 540-00-000 LOT 75736
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 51 YR