MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER E1 HUMERAL BEARING; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	EP-115394
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Discomfort (2330)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: associated product information, part (lot): - 434903611 (63862893).- 211215 (260890).- 211263 (216430).- 434902502 (63869256).- 115370 (457360).- 434903611 (63862893).- 211228 (533480).- 211228 (301870).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 that a patient had an initial right reverse total shoulder arthroplasty.Subsequently, 10 months post-implantation it was reported that the patient experiences stiffness with rom and significant deltoid weakness.The patient received a cortisone injection and additional physical therapy that focused on anterior deltoid strengthening approximately two months post-implantation.The patient noted no further complications and the adverse events resolved.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The reported event is not confirmed.Product has not been evaluated as it has been determined the event is not related to device.This is a limited investigation, a review of the device history record and complaint history review will not be completed for limited investigation complaints as the product meets the applicable acceptance criteria.Review of the reported event by a health care professional found: atrophy is a deconditioning of the muscles from lack of or limited use.Physical therapy or home exercises are prescribed before and after a total joint procedure to keep the muscles strong and stable.Recovery from the physical disruption of surgery is dependent on the patient's comorbidities and ability to withstand postop therapy.Atrophy can result in difficulty ambulating, imbalance, range of motion of a joint and weakness which can further contribute to swelling with lack of use.Atrophy can usually be reversed with stretching, exercises, and increased movement.The root cause of the reported event was determined to be unrelated to the device.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.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER E1 HUMERAL BEARING
• 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: 22738839
• Report Number: 0001825034-2025-02392
• Device Sequence Number: 7218497
• Product Code: PHX
• UDI-Device Identifier: 00880304543188
• UDI-Public: (01)00880304543188(17)220616(10)691380
• 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: 2018
• 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
• Report Date (Section B): 12/16/2025

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 Expiration Date: 06/16/2022
• Device Catalogue Number: EP-115394
• Device Lot Number: 691380
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White