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

Catalog Number 114915

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

Patient Problem Bone Fracture(s) (1870)

Event Date 05/14/2019

Event Type  Injury  

Event Description

Revision surgery - due to the humeral component becoming loose and the patient having slight fracture.

Manufacturer Narrative

The reason for this revision surgery was due to loose component.The previous surgery and the surgery detailed in this investigation occurred 3.4 years apart.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 implant device history records (dhr), shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complainthe root cause of this complaint was a revision surgery due to loose component.There were no findings during this investigation that indicate that the reported device was 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 of the control of djo surgical.There are no indications t history of the reported device showed no present trends or on-going issues that are in need of review.Of a product or process issue affecting implant safety or effectiveness.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC HUM 4X150MM RT FLANGED C
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8696622
• MDR Text Key: 147926303
• Report Number: 1644408-2019-00531
• 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: 07/11/2019

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 114915
• Device Lot Number: 810710
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 06/14/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114700, LOT 763110; 114700, LOT 763110
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR