MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE +3 MM LATERAL OFFSET 40 MM DIAMETER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number 110030777

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 02/07/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00544 & 0001822565-2023-00545.Concomitant medical products; item#: 110031405, mini humeral tray standard thickness +6 mm taper offset 40 mm diameter; lot#: 65587840.Item#: 110031428, bearing +3 mm thickness 40 mm diameter; lot#: 65592546.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product was requested from hospital but not released by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a right shoulder arthroplasty.Subsequently, the patient underwent a revision surgery approximately two (2) and a half months later due to post operative drainage, a hematoma, and bleeding in the shoulder joint.There were no signs of an infection as the patient's white blood cell count was not found intraoperative.There is no additional information available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00544-1 and 0001822565-2023-00545-1.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure or trauma and can predispose the patient to infection.The development of a postoperative hematoma can be correlated with the surgical procedure and perioperative anticoagulation therapy prescribed to prevent thrombus formation.Most hematomas resolve on their own, without surgical intervention, while some do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.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

No further event information available at the time of this report.

• Brand Name: GLENOSPHERE +3 MM LATERAL OFFSET 40 MM DIAMETER
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16460231
• MDR Text Key: 310429551
• Report Number: 0001822565-2023-00543
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00887868231261
• UDI-Public: (01)00887868231261(17)320619(10)65369821
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 110030777
• Device Catalogue Number: 110030777
• Device Lot Number: 65369821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male