MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAESTRO TOTAL WRIST CARPAL HEAD 7X15MM STD; PROSTHESIS, WRIST

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 05/20/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 180181 maestro radial stem 6.0x40mm 635990; 180120 maestro capitate stem 6x12mm 303280; 180151 maestro rad w/brg 7x15 7.5 rt 294070; 180103 maestro carp plate 9x37 aug 6 697940; 113846 titanium screw low prof 5x30mm 472030; 113843 titanium screw low prof 5x15mm 349570.The complaint cannot be confirmed with limited information received.Review of device history records found these units were released to distribution with no deviations or anomalies.Root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04638 , 0001825034 - 2018 - 04639 , 0001825034 - 2018 - 04641 , 0001825034 - 2018 - 04644.

Event Description

It was reported that the patient underwent a wrist revision due to unknown reasons five years post primary surgery.No additional information is available.

• Brand Name: MAESTRO TOTAL WRIST CARPAL HEAD 7X15MM STD
• Type of Device: PROSTHESIS, WRIST
• 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: 7758305
• MDR Text Key: 116365089
• Report Number: 0001825034-2018-04648
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 180063
• Device Lot Number: 961010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2005
• 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