MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD RGX AUG - SM; PROSTHESIS, SHOULDER

Catalog Number	211228
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: e1 44-36 std hmrl brng cat# ep-115393, lot# 719450, compr srs prox bdy - sm 48mm cat# 211215, lot# 179160, compr srs mod stem - 10x150mm cat# 211243, lot# 986950, comp rvs tray co 44mm cat# 115370, lot# 341440, compr srs mod rgx aug - sm cat# 211228, lot# 005950.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported a patient was treated with a cortisone injection and pt 9 months post implantation due to shoulder stiffness and pain.All implants remain implanted.No revision is scheduled.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h2, h3, h4, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: 1 month postop: developed left elbow olecranon bursitis after l-shoulder surgery; resolved with cortisone injection 3 months later.Mild in severity (not calling out due to bursitis is related to elbow and not shoulder) cortisone injection administered in office, resolved symptoms by follow-up.9 months postop: patient noted persistent l-shoulder stiffness during follow-up visits, receiving pt and deltoid injections for management.Ongoing as of last office visit 2 years post op.Mild in severity.Pt prescribed for shoulder stiffness; injections given for pain management.A definitive root cause cannot be determined.The reported event is unconfirmed.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 is available at the time of this report.

• Brand Name: COMPR SRS MOD RGX AUG - SM
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 23575777
• Report Number: 0001825034-2025-03663
• Device Sequence Number: 18467850
• Product Code: PHX
• UDI-Device Identifier: 00880304507876
• UDI-Public: (01)00880304507876(17)281228(10)005970
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173411
• 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
• Report Date (Section B): 04/29/2026

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 Catalogue Number: 211228
• Device Lot Number: 005970
• 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
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2018
• 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
• Patient Age: 82 YR
• Patient Sex: Female