MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD RGX AUG - SM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	211228
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: unknown, unknown glenoid; lot#: unknown.Item#: 211215, compr srs prox bdy - sm 48mm; lot#: 965930.Item#: 211238, compr srs mod stem - 12x100mm; lot#: 092190.Item#: 115375, comp rvs tray +5mm co 44mm; lot#: 637540.Item#: ep-115393, e1 44-36 std hmrl brng; lot#: 256980.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial left shoulder arthroplasty on and unknown date.Subsequently, the patient underwent a surgical procedure approximately seven (7) years and three (3) months ago where they had a manipulation with lysis of adhesion and rotator cuff repair due to limited range of motion and persistent pain.
Event or Problem Description
It was reported that a patient had a revision left reverse total shoulder arthroplasty approximately eight (8) years and 1 month ago with another revision approximately four (4) months later due to pain and scar tissue.Subsequently, approximately six (6) years and four (4) months ago the patient had a manipulation with lysis of adhesion and rotator cuff repair due to limited range of motion and persistent pain.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2.D10: medical products: item#: unknown, unknown tm baseplate 25mm; lot#: unknown.Item#: 211215, compr srs prox bdy - sm 48mm; lot#: 965930.Item#: 211238, compr srs mod stem - 12x100mm; lot#: 092190.Item#: 115375, comp rvs tray +5mm co 44mm; lot#: 637540.Item#: ep-115393, e1 44-36 std hmrl brng; lot#: 256980.Item#: unknown, unknown 36mm screw; lot#: unknown.Item#: unknown, unknown 42mm screw; lot#: unknown.Item#: unknown, unknown 36mm glenosphere; lot#: unknown.H10: related report number: 0001825034-2025-02231.0001825034-2025-02232.0001825034-2025-02233.0001825034-2025-02234.0001825034-2025-02235.Once the investigation has been completed, a follow-up mdr will be submitted.
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, h6, h11.H11: 0001825034-2025-02231, 0001825034-2025-02232 , 0001825034-2025-02233 , 0001825034-2025-02234 , 0001825034-2025-02235 , 0001825034-2025-02631, 0001825034-2025-02632, 0001825034-2025-02633.Product has not been evaluated as it has been determined the event is not related to device.Root cause of the reported event is not device related.Arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.The event is confirmed.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, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 22608227
• Report Number: 0001825034-2025-02236
• Device Sequence Number: 14798616
• Product Code: KWT
• UDI-Device Identifier: 00880304507876
• UDI-Public: (01)00880304507876(17)270908(10)072300
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K223631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 12/03/2025

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: 211228
• Device Lot Number: 072300
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 07/24/2025; 11/07/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/22/2025; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White