MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISCOVERY SCREW - HEXALOBULAR

Catalog Number 114993

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Revision surgery - due to the proxim stem loosening (non- djo product); it was also indicated to have the distal elbow removed.Information was received the patient instead elected for amputation.(originally implanted (b)(6) 2011).

Manufacturer Narrative

Corrected data: removed the primary/main part and 2 of the concomitants.Manufacturer narrative: upon quality assurance evaluation, 2 of the concomitant parts were removed and it was determined that the main part was an unknown part.This mdr will be voided.Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review shall be conducted.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISCOVERY SCREW - HEXALOBULAR
• 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: 7010553
• MDR Text Key: 91365187
• Report Number: 1644408-2017-00972
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225762
• UDI-Public: (01)00888912225762
• 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: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114993
• Device Lot Number: 716040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2018
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: 114700,LOT 077190; 114812,LOT 791070; 114993,LOT 992810
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR