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

Catalog Number	115340
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Scar Tissue (2060); Joint Dislocation (2374); Subluxation (4525)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision of a left reverse total shoulder arthroplasty due to subluxation.It was reported that the glenosphere had dislocated.During the revision, the polyethylene insert was reported to show partial wear and was removed, and overgrowth of scar tissue at the glenoid baseplate was removed.The glenoid baseplate was reported to be integrated and was retained, and a replacement glenosphere was secured to it.The humeral cup was reported to be well fixed, and when the insert could not be placed without difficulty the humeral cup was removed and its taper was reported to be altered.The glenosphere, taper adaptor, humeral bearing and humeral tray were reported to have been explanted and replaced, and the humeral stem was retained.The components were reported to provide good range of motion and to be stable and well fixed, and closure was reported without complications.Due diligence is complete for this complaint; it was reported that no further information is available, and to date no additional information or product has been received.
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): - xl-115366 (157810).- ti-115320 (214900).Associated product information: - 118001 (225630).- 115330 (786740).G2: foreign - the event occurred in germany.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.

• Brand Name: Comprehensive® Reverse Shoulder
• 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; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)527-3773
• MDR Report Key: 50093580
• Report Number: 0001825034-2026-02223
• Device Sequence Number: 13263361
• Product Code: PHX
• UDI-Device Identifier: 00880304475335
• UDI-Public: (01)00880304475335(17)250528(10)259660
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

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 Expiration Date: 05/28/2025
• Device Catalogue Number: 115340
• Device Lot Number: 259660
• 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: 07/02/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2015
• 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