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

Catalog Number 114800

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 11/27/2018

Event Type  Injury  

Event Description

Revision surgery - due to catastrophic failure of the polyethylene.

Manufacturer Narrative

(b)(4).The information for the main component has been removed.Upon further quality assurance evaluation, it was determined that the main component is an unknown discovery part.

Manufacturer Narrative

The reason for this revision surgery was failure of the poly.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.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 complaint evaluation was limited in scope since the part associated with this investigation was not returned to djo surgical for evaluation.A review of the device history records (dhr) was not conducted since the item and or lot number was not provided or determined during the complaint evaluation.Given the limited information, a search for an invoice of the previous surgery could not be conducted.As of 22 jan 2019, the records needed have not been forwarded by zimmer-biomet.Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to failure of the poly.There was no information submitted with the complaint that would indicate a material, design, or manufacturing issue(s) with the explanted part.The length of in-vivo service is unknown since an original surgery date was not provided or could be established.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.

• 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: 8162801
• MDR Text Key: 130309390
• Report Number: 1644408-2018-01138
• Device Sequence Number: 1
• Product Code: JDC
• 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,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 114800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention