MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 44-36 STD HMRL BRNG; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	EP-115393
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Tendinopathy (4887)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part (lot): 115370(795990), 211216(222230), 211237(321180), 211228(978020), associated product information: 00434903611(64107232), 00434903611(64227258).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 or Problem Description
It was reported the patient had a initial left reverse total shoulder.Subsequently, it was reported approximately 5 year post-implantation the patient received 3 separate cortisone injections due to pain and signs of tendonitis.The event was reported as resolved.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a1; a2; a4; b4; b5; b6; b7; d2; e1; e2; e3; g1; g2; g3; g6; h1; h2; h6; h10.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 or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h4, h6, h11.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 on the patients' ability to use the joint to their full potential.Patients 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.Heterotopic ossification (ho) is the abnormal and rapid growth of bone that forms within soft tissue as the result of heredity, trauma, surgical history, or diseases of a joint.The rapid and irregular growth of bone often causes a sharp or jutted structure to form, which can result in pain and irritation to the surrounding tissues, or the patient can remain asymptomatic.Radiation or nonsteroidal anti-inflammatory medications are often provided to prevent ho formation.The only treatment, if necessary, is surgical excision or shaving/smoothing out the excess bone.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The root cause of the reported event was determined to be unrelated to the device.If any further information is found 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
No further event information is available at the time of this report.

• Brand Name: E1 44-36 STD HMRL BRNG
• 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: 23100075
• Report Number: 0001825034-2025-02958
• Device Sequence Number: 8685816
• Product Code: PHX
• UDI-Device Identifier: 00880304543157
• UDI-Public: (01)00880304543157(17)240219(10)247950
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2026

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 Expiration Date: 02/19/2024
• Device Catalogue Number: EP-115393
• Device Lot Number: 247950
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 01/05/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/16/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White