MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER SYSTEM VIVACIT-E- HIGHLY CROSSLINKED POLYETHYLENE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110031424
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had a primary shoulder arthroplasty.Subsequently, approximately 3 years later, the patient underwent a revision procedure due to a dislocation.The humeral head and glenoid components were removed and replaced.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: associated product information, part (lot): - 115310(927920).G2: foreign - the event occurred in australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation since it was not returned by the hospitaln.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d1; d2; g1; g3; g6; h1; h2; h3; h4; h6.D10: associated product information, part (lot): -010000589 (161220), -110031402 (64808960), -180552 (60640), -113612 (64877512), -180553 (246180), -405889 (834470), -110031424 (64862407), -115395 (105040), -405800 (94530), -405883 (923930), -180551 (482110).The reported event is not confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The photos provided are screenshots of the part numbers.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER SYSTEM VIVACIT-E- HIGHLY CROSSLINKED POLYETHYLENE
• 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 ; 5745260384
• MDR Report Key: 22663300
• Report Number: 0001822565-2025-02719
• Device Sequence Number: 19752350
• Product Code: PHX
• UDI-Device Identifier: 00887868231551
• UDI-Public: (01)00887868231551(17)251129(10)64862407
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 11/29/2025
• Device Catalogue Number: 110031424
• Device Lot Number: 64862407
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown