MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 5X100MM RT FLANGED C

Catalog Number 114907

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/06/2017

Event Type  Injury  

Event Description

Revision surgery - the patient was revised because of a peri-prosthetic fracture.There was nothing wrong with the product.

Manufacturer Narrative

The reason for this revision surgery was due to the patient having a peri-prosthetic fracture.The actual length of in-vivo patient service for this product is unknown as the original surgery date was not provided or could be established.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 and product complaint report history for this product could not be conducted due to no part or lot number being reported.Multiple searches of the djo surgical records by surgeon and patient database revealed no additional information concerning this event.No additional information was obtained from the agent to assist in the event identification.This complaint is deemed to be non-product related.The complaint states the patient had a peri-prosthetic fracture of the elbow.The length of in-vivo service is unknown since an original surgery date was not provided or could be established.No other conditions relating to this event could be determined with confidence.The surgeon reported no issues associated with the explanted product.The complaint investigation is limited in scope since the part associated with this investigation was not returned to djo surgical for evaluation.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC HUM 5X100MM RT FLANGED C
• 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: 7053746
• MDR Text Key: 92790009
• Report Number: 1644408-2017-01059
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225496
• UDI-Public: (01)00888912225496
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

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: 114907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 12/15/2017
• 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: 80 YR