MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA BEARING KIT

Catalog Number 114800

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 02/22/2018

Event Type  Injury  

Event Description

Revision surgery - due to the pin becoming loose and malfunctioning, causing polyethylene failure.

Manufacturer Narrative

The reason for this revision surgery was due to pin malfunction causing polyethylene failure.The previous surgery and the revision detailed in this investigation occurred 6.9 years apart.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 record (dhr) was not conducted since the item and or lot number(s) was not provided or determined during the complaint evaluation.No additional information was obtained to assist in the event identification.As of 27-mar-2018, no records have been forwarded by zimmer-biomet concerning this event.Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review shall be conducted.The root cause of this complaint was a revision surgery due to pin malfunction causing polyethylene failure.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.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 ULNA BEARING KIT
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7317639
• MDR Text Key: 101634665
• Report Number: 1644408-2018-00186
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225083
• UDI-Public: (01)00888912225083
• 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: 03/28/2018

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: 114800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114700; 114700
• Patient Outcome(s): Required Intervention