MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP REV CR VIVACIT-E 40MM BRNG STD; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	110031427
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 110031405, mini tray std cocr +6 offset; lot#: 66963307.Item#: 110030776, standard offset 40mm diameter glenosphere; lot#: 66783629.G2: foreign: australia h3: customer has indicated that the product will not be returned to zimmer biomet for investigation, product was requested from the hospital but not returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty approximately four (4) months ago.Subsequently, the patient underwent a revision surgery due to the bearing and humeral tray to disassociate, causing the glenosphere to dislocate from the bearing.Attempts have been made to obtain additional information.No additional information has been received at this time.
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty approximately three months post-implantation.Subsequently, the patient underwent a revision surgery due to dislocation and disassociation of the glenosphere and taper adapter from the glenoid baseplate.No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, d10, g3, g6, h2, h3, h6, h10, h11.Corrected data: h4.D10: concomitant medical products.Item name: comp aug mini bsplt w tpr sm; item 110032410; lot 66874277.Visual examination of the provided pictures identified a glenosphere, taper, tray, and bearing after explanation.The part and lot information etched on the bearing and glenosphere match the reported part and lot numbers.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.A review of complaint history identified additional similar complaints for the reported items and no additional related complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMP REV CR VIVACIT-E 40MM BRNG STD
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• 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: 22366888
• Report Number: 0001822565-2025-02237
• Device Sequence Number: 18122482
• Product Code: PHX
• UDI-Device Identifier: 00887868231582
• UDI-Public: (01)00887868231582(17)290825(10)66874225
• 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: 2025
• 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): 10/29/2025

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 Catalogue Number: 110031427
• Device Lot Number: 66874225
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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
• Patient Weight: 105 KG