MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP CNV GLEN BASE NON HA; PROSTHESIS, SHOULDER

Catalog Number	110005273
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Subluxation (4525)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: literature - cirino, carl m.; peterson, joel r.; williams, anna b.; cecere, robert a.; finocchiaro, anthony; chabot, peter j.; gulotta, lawrence v.(2026).Short-term outcomes of bone grafting in conjunction with the comprehensive total shoulder system with a convertible metal-backed glenoid.Elsevier, 35, e208-215.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 through a journal article that one patient was revised approximately 3.5 years postoperatively to a reverse shoulder arthroplasty due to recurrent posterior subluxation, pain, and decreased range of motion and strength.During the revision procedure, the convertible baseplate was retained and converted, and the bone graft from the index surgery demonstrated complete integration.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: a4, b4, b5, b7, g3, g6, h2, h11.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported through a journal article that one patient was revised approximately 3.5 years postoperatively to a reverse shoulder arthroplasty due to recurrent posterior subluxation, pain, and decreased range of motion and strength.During the revision procedure, the convertible baseplate was retained and converted, and the bone graft from the index surgery demonstrated complete integration.It was further noted that the onset of pain was approximately 24 months post implantation, and the patient never fully achieved full rom post implantation.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, d1, d4, g4, h2, h6, h11.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMP CNV GLEN BASE NON HA
• 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: 24390170
• Report Number: 0001825034-2026-00393
• Device Sequence Number: 10518929
• Product Code: PHX
• UDI-Device Identifier: 00880304568105
• UDI-Public: (01)00880304568105(17)270801(10)434010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/16/2026

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: 110005273
• Device Lot Number: 434010
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/05/2026; 04/13/2026; 05/20/2026; 06/16/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/01/2026; 05/01/2026; 05/21/2026; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK HEAD CAT#UNKLOT#UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Patient Weight: 91 KG