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

Model Number	110031428
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event: 0001822565-2023-00543 and 0001822565-2023-00544.Concomitant medical products: item#: 110030777, glenosphere +3 mm lateral offset 40 mm diameter, lot#: 65369821; item#: 110031405, mini humeral tray standard thickness +6 mm taper offset 40 mm diameter, lot#: 65587840.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.
Additional 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: 0001822565-2023-00543-1, 0001822565-2023-00544-1.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: BEARING +3 MM THICKNESS 40 MM DIAMETER
• Common Device Name: 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: 16460223
• Report Number: 0001822565-2023-00545
• Device Sequence Number: 16767595
• Product Code: KWS
• UDI-Device Identifier: 00887868231599
• UDI-Public: (01)00887868231599(17)270929(10)65592546
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 110031428
• Device Catalogue Number: 110031428
• Device Lot Number: 65592546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male