MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 3X75MM LT W BRNG C

Catalog Number 114812

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 02/22/2019

Event Type  Injury  

Event Description

Revision surgery - due to an infection.11 months post total elbow arthroplasty for fracture.

Manufacturer Narrative

Concomitant medical products corrected.

Manufacturer Narrative

The reason for this revision surgery was due to an infection.The previous surgery and the revision detailed in this investigation occurred 10.9 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 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 ulna (114812) used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports associated with the component that may have contributed to the infection.The device was within the expiration date at the time of use during the previous surgery.As of (b)(6) 2019 no device history records (dhr) have been forwarded by zimmer-biomet concerning the items: 114904 & 114700 in this complaint.Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to an infection.There were no findings during this investigation that indicate that the reported device 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.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 3X75MM LT W BRNG C
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8442467
• MDR Text Key: 139532243
• Report Number: 1644408-2019-00217
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225144
• UDI-Public: (01)00888912225144
• 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,Followup
• Report Date: 07/30/2019

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: 09/12/2022
• Device Catalogue Number: 114812
• Device Lot Number: 756060
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 05/21/2019; 07/03/2019
• Supplement Dates FDA Received: 06/20/2019; 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114700 LOT 612700; 114904; 114904 LOT 842310; 114904, LOT 842310; 540-00-000; 540-00-000, LOT 612700; 114904; 540-00-000
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR