MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE VIVACIT-E STANDARD 36MM DIAMETER BEARING; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	110031424
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 110031399, mini standard thickness +0mm taper offset 40mm diameter humeral tray; lot#: 66664168; item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: 66724696.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 right shoulder arthroplasty on an unknown date.The patient, on an unknown date, began to experience pain and a crunching sound after laying down and rolling over.Subsequently, the patient underwent a revision surgery approximately four (4) months ago due to the implants disassociating.Attempt has 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 right shoulder arthroplasty approximately five (5) months ago.The patient rolled over while laying down and had pain along with a crunch sound after when moving their shoulder, imaging revealed that the humeral bearing had disassociated from the humeral tray.Subsequently, the patient underwent a revision surgery approximately three (3) months after the initial surgery due to the implants disassociating.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.Once the investigation has been completed, a follow-up mdr will be submitted.
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; d2; g2; g3; g6; h1; h2; h3; h6.The following sections were corrected: d9; h4.Visual examination of the returned product identified item showed signs of use and wear.The bearing has damage to the locking feature and some of the material is peeled back.Dimensional analysis was not performed on the bearing due to the damage.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right reverse total shoulder arthroplasty with disassembly of the polyethylene humeral bearing.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMPREHENSIVE VIVACIT-E STANDARD 36MM DIAMETER BEARING
• 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: 21111964
• Report Number: 0001822565-2025-00099
• Device Sequence Number: 7538939
• Product Code: PHX
• UDI-Device Identifier: 00887868231551
• UDI-Public: (01)00887868231551(17)290616(10)66653376
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2025

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: 110031424
• Device Lot Number: 66653376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 01/09/2025; 05/07/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/06/2025; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 86 KG