MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event - onset shortly post-op in (b)(6) 2016.(b)(4).Concomitant products: catalog #: 113635, comp primary stem 15mm mini, lot # 622430; catalog #: 118001, versa-dial/comp ti std taper, lot # 394120; catalog #: 113042, versa-dial 46x18x53 hum head, lot # 861660; catalog #: 110003484, access 3.2mm thd pin, lot # 526330; catalog #: pt-113950, pt hybrid glenoid post, lot # 740040; catalog #: 113952, sm hybrid glenoid, lot # 261700.It is not anticipated that the product will be returned to zimmer biomet for evaluation at this time, as the customer has not provided any further information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-05176, 0001825034-2017-04063, 04064, and 04065.

Event Description

It was reported patient underwent a right shoulder arthroplasty, and subsequently began experiencing angioedema and an allergic reaction shortly following implantation.No revision has been reported to date.

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 (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.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: COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6717750
• MDR Text Key: 80169674
• Report Number: 0001825034-2017-04065
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113042
• Device Lot Number: 861660
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2016
• 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): Required Intervention