MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ARCOMXL; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number XL-115368

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

Patient Problem Insufficient Information (4580)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see the associated reports: ¿ 0001825034-2024-00783; ¿ 0001825034-2024-00784; ¿ 0001825034-2024-00785; ¿ 0001825034-2024-00786; ¿ 0001825034-2024-00787; ¿ 0001825034-2024-00788; ¿ 0001825034-2024-00790.D10: concomitant medical products, part number (lot number): ¿ 211215 (179160); ¿ 211226 (966890); ¿ 211236 (829710); ¿ 211229 (739710); ¿ 115340 (738490); ¿ 118000 (139820); ¿ ti-115323 (620400).E1: full establishment name - (b)(6) hospital.The customer has not indicated whether the product will be zimmer biomet for investigation, and the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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 a patient had a complex revision history of a right reverse total shoulder arthroplasty, including multiple periprosthetic fracture repairs and mrsa infection in the joint.The patient underwent an additional revision due to unknown reasons.Three weeks later, the patient underwent an irrigation and debridement with no reported product exchange.No medical records or additional information has been provided to further detail the event.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ARCOMXL
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18959734
• MDR Text Key: 338366761
• Report Number: 0001825034-2024-00789
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304475830
• UDI-Public: (01)00880304475830(17)200721(10)469610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193373
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2020
• Device Catalogue Number: XL-115368
• Device Lot Number: 469610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female