MAUDE Adverse Event Report: Zimmer Biomet, Inc. Comprehensive® Prolong®; Shoulder Prosthesis, Reverse Configuration

Catalog Number	110031418
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580); Crepitus (4893)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision was performed due to polyethylene dissociation, noted as the second such event within approximately two (2) years.The surgical technique used during the initial procedure was followed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet and the investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: Comprehensive® Prolong®
• Common Device Name: Shoulder Prosthesis, Reverse Configuration
• Manufacturer (Section D): Zimmer Biomet, Inc.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): Zimmer Biomet, Inc.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50143345
• Report Number: 0001822565-2026-02761
• Device Sequence Number: 15790095
• Product Code: PHX
• UDI-Device Identifier: 00887868231490
• UDI-Public: (01)00887868231490(17)301020(10)67445223
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 110031418
• Device Lot Number: 67445223
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2025
• 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: Item Unknown Tray, Lot Unknown.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male