MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC CONDYLE KIT WITH HEXALOBULA

Catalog Number 114700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fracture, Arm (2351)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as fracture.The previous surgery and the surgery detailed in this event occurred 9.4 years 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 device history records (dhr) was not conducted since the item or lot number was not provided or determined during the complaint evaluation.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 a fracture.The length of in-vivo service is unknown since an original surgery date was not provided or could be established.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.Should addition information become available this complaint shall be re-opened and a further evaluation well be conducted.There are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - radius fracture.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC CONDYLE KIT WITH HEXALOBULA
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9050408
• MDR Text Key: 159784732
• Report Number: 1644408-2019-00872
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR