MAUDE Adverse Event Report: Zimmer Biomet, Inc. Comprehensive®; shoulder prosthesis, reverse configuration

Catalog Number	110031405
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Noise, Audible (3273)
Health Effect - Clinical Codes	Joint Dislocation (2374); Crepitus (4893)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a disassociation/dislocation occurred approximately two months after implantation of a right reverse total shoulder arthroplasty.The patient reported a clicking sensation and a feeling that something was "off" prior to presentation.The patient underwent revision, during which the polyethylene bearing was exchanged.No patient injury, sequelae, or outcome was reported beyond the disassociation/dislocation and the revision procedure.The surgical technique used during the initial procedure was indicated to have been followed.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products in the d10 narrative below.D10: concomitant medical products, part (lot): 110031418 (67445223) associated product information: 115310 (j8066658) this report replaces 0001822565-2026-02760, which is being voided after receipt of additional information that determined the event should be documented and reported under this complaint reference.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®
• 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: 50706042
• Report Number: 0001822565-2026-03082
• Device Sequence Number: 18815522
• Product Code: PHX
• UDI-Device Identifier: 00887868231377
• UDI-Public: (01)00887868231377(17)360217(10)67719045
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 08/05/2026

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: 110031405
• Device Lot Number: 67719045
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/22/2026
• 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: 08/12/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2026
• 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: H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male