MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CUSTOM DISCOVERY ULNA W/ 20MM SEGMENTAL BUILD-UP; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr#0001825034-2017-07188.Implant date: (b)(6) 2012.Concomitant medical products: custom mosaic proximal stem w/ attachment to mid-shaft clamp pncp561778 ln645210.Report source, foreign ¿ event occurred in the (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial procedure.Subsequently, the patient was revised due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable.No additional patient consequences were reported.

Manufacturer Narrative

This follow up report is being submitted to report additional information.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a patient underwent a procedure on their custom humeral device and elbow due to unknown reasons.A custom ic clamp was implanted in order to mate with srs distal humerus to mate to the custom ulna.Attempts have been made and additional information on the reported event is unavailable.No additional patient consequences were reported.

• Brand Name: CUSTOM DISCOVERY ULNA W/ 20MM SEGMENTAL BUILD-UP
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7356720
• MDR Text Key: 103000438
• Report Number: 0001825034-2018-01496
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: N/A
• Device Catalogue Number: CP561781
• Device Lot Number: 256930
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR