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

Catalog Number 114700

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 05/15/2017

Event Type  Injury  

Event Description

Revision surgery - due to the humeral stem loosening, a condyle exchange was needed.

Manufacturer Narrative

The reason for this revision surgery was the patient had a humeral stem that was loosening.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.The complaint does state the original implant may have been in-vivo since 2003.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.Initial or prolonged hospitalization was required.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history record (dhr) was not conducted since a lot number was not provided or determined during the complaint evaluation.Multiple searches of the djo surgical records and patient database revealed no additional information concerning this event.This complaint will be closed with the lot unknown pending receipt of additional information.Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review shall be conducted.This complaint is deemed to be non-product related.The complaint states the patient had a humeral stem that was loosening.This revision was necessary to correct the patient's condition.No other conditions, root cause, 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 CONDYLE KIT WITH HEXALOBULA
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• 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: 6641539
• MDR Text Key: 77583009
• Report Number: 1644408-2017-00484
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912224833
• UDI-Public: (01)00888912224833
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

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: 114700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 09/14/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR