MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP REV SHOULDER SYSTEM VIVACIT E POLY BEARING STANDARD 40MM; 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	07/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 110031404, mini +10mm thickness +3mm taper offset 40mm diameter humeral tray; lot#: 64437452.G2: foreign: australia.H3: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 2 (2) months ago.While the patient was at work approximately eight (8) weeks post op the patient was leaning on their operated arm causing the poly to disassociate from the humeral tray and dislocate.Subsequently, the patient underwent a revision surgery eighteen (18) days ago.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.D10: medical products: item#: 110030778, +6mm lateral offset 40mm diameter glenosphere; lot#: 64630398r.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The root cause of the reported issue is attributed to patient noncompliance.If any further information is found which 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
This follow-up report is being submitted to relay additional information.The following sections were corrected: d4, d10, h4.The following sections were updated: b4, b5, d9, g3, g6, h2, h6, h11.D10: mini tray +5mm cocr +3 offset cat# 110031403 lot# 64550813; cr 40mm glenosphere +3mm cocr cat# 110030777 lot# 65942426.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty approximately one (1) year and four (4) months ago.Subsequently, the patient underwent a revision surgery approximately two (2) months later due to the poly disassociating from the humeral tray and dislocation.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.Visual examination of the returned bearing identified signs of use with gouges and damage across much of the surface of the bearing and deformation / damage to the locking features.Dimensional analysis of the overall width of the bearing found it was conforming to print specification.No other measurements were taken due to the damage of the bearing.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Further information provided by the surgeon indicated the patient was not leaning on the operated arm.This information was provided in error.As such, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMP REV SHOULDER SYSTEM VIVACIT E POLY BEARING STANDARD 40MM
• 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: 19799500
• Report Number: 0001822565-2024-02438
• Device Sequence Number: 7453892
• Product Code: PHX
• UDI-Device Identifier: 00887868231582
• UDI-Public: (01)00887868231582(17)280909(10)66138564
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/29/2025

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: Health Professional
• Device Catalogue Number: 110031427
• Device Lot Number: 66138564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 10/02/2024; 10/30/2024; 02/20/2025; 09/24/2025
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 10/24/2024; 11/08/2024; 03/18/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 120 KG