MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP CONV GLEN LINER VIVACIT-E; PROSTHESIS, SHOULDER

Catalog Number	110035767
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been 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 that during surgery, the liner could not be seated as intended in the corresponding component during an unspecified procedure.No additional details were provided regarding the setting, handling, or environmental conditions at the time of the event.Patient involvement was not reported; no known impact or consequence to the patient was provided.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: d4; h2; h3; h4; h6; h11.The reported event could not be confirmed.Visual examination of the returned product identified the liner has several visible scratches on the articulating surface.There is damage to the large peg on the bottom of the liner including gouges and scratches.Two of the four small pegs on the device also have damage to them including indentations and scratches.The damaged small pegs also have positive material on them.Product identifiers were measured and found conforming to print specifications.Medical records were not provided.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: COMP CONV GLEN LINER VIVACIT-E
• 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: 23544116
• Report Number: 0001825034-2025-03600
• Device Sequence Number: 15896476
• Product Code: PHX
• UDI-Device Identifier: 00887868249334
• UDI-Public: (01)00887868249334(17)280712(10)65794150
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K211729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110035767
• Device Lot Number: 65794150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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
• Patient Sex: Female