MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE BASE PLATE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Pain (1994); Distress (2329); Discomfort (2330); Neck Pain (2433)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unknown, reverse shoulder system, unknown, unknown, unknown humeral liner, unknown , unknown, unknown glenoid head, unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06522, 0001822565 - 2017 - 06523, 0001822565 - 2017 - 06524.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 the patient underwent total reverse shoulder implant surgery.Subsequently, the patient experiences pain radiating from upper arm, across shoulder joint, into upper chest, throat area, and neck area.Pain and severe discomfort occur nightly while sleeping, causing wakefulness and distress for approximately 15-20 minutes.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Concomitant medical products: 00434900813, tm stem 3 reverse 8 mm x 13, 60972092.The 00434903603, tm rev hum poly lnr/inlays, 61521207.The 00434903611, tm reverse 36 mm glenosphere, 61600008.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-06524-1, 0001822565-2017-06522-1, 0001822565-2017-06523-1.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: TM REVERSE BASE PLATE
• Type of Device: PROSTHESIS, SHOULDER
• 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: 6876999
• MDR Text Key: 86701254
• Report Number: 0001822565-2017-06525
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00434903811
• Device Lot Number: 61615217
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2010
• 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): Other
• Patient Weight: 91