MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE STANDARD TAPER ADAPTER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Numbness (2415)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: comprehensive standard taper adapter, catalog#: 118001 lot#: 743940, comprehensive modular head, catalog#: 113034 lot#: 260990, comprehensive hybrid glenoid base, catalog#: 113952 lot#: 551410, comprehensive hybrid glenoid post, catalog#: pt-113950 lot#: 470030.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-00503, 0001825034-2018-00504, 0001825034-2018-00505, 0001825034-2018-00506, 0001825034-2018-00507.No device or photos were received; therefore the condition of the component is unknown.Dhr was reviewed and no discrepancies relevant to the reported event were found.In the medical records, it is noted that the patient had pain and tenderness at 6 weeks postop; pain and tenderness at 3 months postop, instability/translation at 1 year postop, and no alleged issues at 2 years postop.Root cause could not 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.Remains implanted.

Event Description

It was reported that the patient is experiencing pain, numbness and instability in the shoulder and arm.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: COMPREHENSIVE STANDARD TAPER ADAPTER
• 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: 7230288
• MDR Text Key: 98644807
• Report Number: 0001825034-2018-00504
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 743940
• Other Device ID Number: 0 0880304 21724 9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2015
• 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 Age: 59 YR
• Patient Weight: 77