MAUDE Adverse Event Report: ENCORE MEDICAL L.P DISCOVERY ELBOW; DISC ULNA 5X75MM LT W/BRNG C

Catalog Number 540-15-075

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

Patient Problem Unspecified Infection (1930)

Event Date 03/24/2021

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

Revision surgery - patient became infected causing implant loosening.Revision surgery was required.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as an infection.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.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.This investigation is limited in scope as only partial information was provided to djo surgical for review.The revised item was not returned for examination and lot numbers was not provided.To adequately investigate this event, lot numbers are necessary.In addition to the lot numbers not being supplied, information regarding cultures identified in the infection and the severity of the infection was not supplied.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.The root cause of this complaint was reported as an infection.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.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 5X75MM LT W/BRNG C
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd.; austin,tx 78758-5445
• MDR Report Key: 11700397
• MDR Text Key: 246469004
• Report Number: 1644408-2021-00314
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

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 Catalogue Number: 540-15-075
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 04/30/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 540-00-000 LOT UNKNOWN; 540-46-100 LOT UNKNOWN; 540-00-000 LOT UNKNOWN; 540-46-100 LOT UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR