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

Catalog Number 114829

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 07/18/2019

Event Type  Injury  

Event Description

Revision surgery - patient had infection, hence washed out and replaced with new condyle kit.

Manufacturer Narrative

Corrected data: see d2; d4; d11.Narrative data: the reason for this revision surgery was due infection.The previous revision surgery and the revision surgery detailed in this event occurred 12.1 months apart.The healthcare professional indicated there was no significant adverse event to the patient.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.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.A review of the device history records could not be conducted.Because of the acquisition by djo surgical, an extended search of zimmer biomet records cannot be conducted.Any records before the acquisition date, that have not been forwarded, will not be made available.Customer complaint history of the reported device 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 investigation that indicate that the reported device was defective.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.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 4X155MM RT W BRNG C
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8903277
• MDR Text Key: 154683425
• Report Number: 1644408-2019-00769
• 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: 10/02/2019

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: 06/07/2021
• Device Catalogue Number: 114829
• Device Lot Number: 169890
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 09/03/2019
• Supplement Dates FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: 114700 LOT 021160.; 114700. LOT 522660.
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR