MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 4X100MM LT FLANGED C

Catalog Number 114904

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Code Available (3191)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to these documents as soon as it becomes available.

Event Description

Revision surgery - humerus was loose in the cement, patient did not have any trauma.Representative only knows that the primary surgery was done 8 years ago, not sure of the location.

Manufacturer Narrative

The reason for this revision surgery was reported as 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.Representative only knows that the primary surgery was done 8 years ago.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.The revised items was not returned for examination and the lot numbers were not provided.To adequately investigate this event, the lot numbers are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.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.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC HUM 4X100MM LT FLANGED C
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9694119
• MDR Text Key: 178741919
• Report Number: 1644408-2020-00089
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114904
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114700 LOT UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR