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

Catalog Number	115313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tendinopathy (4887)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item#: 211215; lot#: 261090, item#: 211239; lot#: 237200, item#: 110032410; lot#: 64362991, item#: 110031399; lot#: 64500139, item#: 110031424; lot#: 64336641, item#: 211228; lot#: 005970, item#: 211228; lot#: 978020.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the reported event by a health care professional found: tendonitis is the inflammation or irritation of the tendons and is typically caused by repetitive motion, overuse and pressure to the bursae.Symptoms the patient can experience, pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.This can impact the patients¿ ability to use the joint to their full potential.Patient can experience a decrease with overall adls, rom of the joint, decrease in quality of life, as well as increasing the need for possible over the counter (otc) medications for swelling and pain control.Treatment for tendonitis can consist of, otc medications, such as tylenol and anti-inflammatories, prescribed pain medications, physical therapy, rest, ice, elevating the affected joint and steroid injections.The root cause of the reported event was determined to be unrelated to the device.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent an initial left reverse total shoulder arthroplasty approximately six (6) years and two (2) months ago as part of a clinical study.Subsequently, the patient developed tendonitis approximately one (1) year and four (4) months post-implantation and was treated with steroid injections and physical therapy.The event was noted to have resolved one (1) month later.Attempts have been made and no further information has been provided.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE
• Common Device Name: 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: 23596162
• Report Number: 0001825034-2025-03704
• Device Sequence Number: 21405296
• Product Code: PHX
• UDI-Device Identifier: 00880304475779
• UDI-Public: (01)00880304475779(17)290826(10)289020
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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: Lay User/Patient
• Device Catalogue Number: 115313
• Device Lot Number: 289020
• 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: 10/30/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White