MAUDE Adverse Event Report: ENCORE MEDICAL L.P DISCOVERY ELBOW; DISC ULNA BEARING KIT

Catalog Number 114800

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - revision due to aseptic loosening.

Manufacturer Narrative

The reason for this revision surgery was reported as aseptic loosening.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 the 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 items were not returned for examination and the item and lot numbers were not provided.To adequately investigate this event, the part and lot numbers are necessary.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 a revision surgery due to aseptic loosening.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.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 BEARING KIT
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 10920114
• MDR Text Key: 218703156
• Report Number: 1644408-2020-01114
• 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: 03/05/2021

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: 114800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114700 LOT UNKNOWN; 114700 LOT UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR