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

Catalog Number 114700

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 12/12/2016

Event Type  Injury  

Event Description

Revision surgery - due to the condyles being completley out, and screws out.Reason is unknown.Patient does not know what he did.Poly bearing was scratched.

Manufacturer Narrative

The reason for this revision surgery was the patient's condyles and screws were completely out.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 healthcare professional indicated there was a significant adverse event to the patient.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 record (dhr) was not conducted since a lot number was not provided or determined during the complaint evaluation.A search of the device investigation produced no anomalies or evidence of a product issue.The implant in-vivo service length is unknown without an original surgery date.Multiple searches of the djo surgical records and patient database revealed no additional information concerning this event.Zimmer-biomet was contacted for additional information through an invoice search and reported they have no additional information to report for this evaluation.This complaint will be closed with the lot unknown pending receipt of additional information.Should additional information become available 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 root cause for the condyles and screws being out was not reported.No other conditions relating to this event could be determined with confidence.The surgeon did report the poly bearing was scratched, no root cause was reported for this.The complaint investigation is limited in scope since the part (s) associated with this investigation was not returned to djo surgical for evaluation.No further action is deemed necessary.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC CONDYLE KIT W/ 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 ; 5128346255
• MDR Report Key: 6231833
• MDR Text Key: 64128428
• Report Number: 1644408-2016-01082
• 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: 03/29/2017

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
• Initial Date Manufacturer Received: 12/12/2016
• Initial Date FDA Received: 01/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• 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): Other; Required Intervention
• Patient Age: 81 YR