MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 3X115MM LT W/ E+ BRNG

Catalog Number 540-53-115

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 05/24/2021

Event Type  Injury  

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

Second revision surgery - infection caused humeral loosening.

Manufacturer Narrative

Corrected data: see d.1., d.2., d.4., d.10.& g.1.Manufacuturer narrative: the reason for this revision surgery was reported as an infection.The previous surgery and the surgery detailed in this event occurred 10.1 months 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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the 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.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 an infection.There were no findings during this evaluation that indicate that the reported devices was the source or had a direct connection with the patient's infection.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 infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside of 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: DISCOVERY ELBOW
• Type of Device: DISC ULNA 3X115MM LT W/ E+ BRNG
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin, tx 78758-5445
• MDR Report Key: 11996817
• MDR Text Key: 256150378
• Report Number: 1644408-2021-00511
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 540-53-115
• Device Lot Number: 822W1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114904 LOT 547770; 540-00-000 LOT 84174; 540-00-000 LOT 84174; 540-53-115 LOT 822W1000; 540-00-000 LOT 84174; 540-53-115 LOT 822W1000
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR