MAUDE Adverse Event Report: ENCORE MEDICAL L. P. DISCOVERY ELBOW; DISC ULNA 4X155MM LT W BRNG C

Catalog Number 114828

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Fifth revision surgery - due to humeral fracture.Went with a biomet long stem and put djo bearings on there.

Manufacturer Narrative

The reason for this revision surgery was reported as humeral fracture.The previous surgery and the surgery detailed in this event occurred 1.5 months apart.The in vivo time for the main part of the complaint is 2.8 years from the primary 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 devices were disposed of at hospital and not made available to djo surgical for examination.Item: 114828.The device history record was not found among djo and available zimmer biomet records.Item: 540-00-000.A review of the 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 verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.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 fracture.The findings did not lead to a firm conclusion since the needed records were not made available at the time of this investigation.No 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 as soon as it becomes available.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 4X155MM LT W BRNG C
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 11702468
• MDR Text Key: 246655947
• Report Number: 1644408-2021-00341
• 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: 06/15/2021

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: 06/17/2022
• Device Catalogue Number: 114828
• Device Lot Number: 543760
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 540-00-000, LOT 81516.
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR