MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X45MM ST/RST; PROSTHESIS, SHOULDER

Catalog Number	115399
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: pn: pm0003907 ln: 014940 eade rt pm mini rvs glenoid.Pn: 110030776 cr 40mm glenosphere std cocr ln: 65311886.Pn: 110031402 mini tray std cocr +3 offset ln: 65163610.Pn: 110031427 cr vivacit-e 40mm brng std ln: 65164149.G2: foreign- australia.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.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
It was reported that the patient's right shoulder was revised due to glenosphere dissociating from the vrs and the central screw loose or backing out.No additional patient consequences were reported.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g3, g6, h1, h2, h3, h6, h11 complaint sample was evaluated and the reported event was confirmed.Visual examination of the screw returned shows sign of use and wear and tear.The hex feature of the screw is damaged and there is some bio debris in the threads of the screw.Review of the available x-rays identified the following: right reverse tsa with separation of the glenosphere and associated dislocation of the glenohumeral joint.Bony fragments are seen in the joint space, possibly evidence of a fracture.Question mild osteopenia.Devices are used for treatment.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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 RVS CNTRL 6.5X45MM ST/RST
• 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: 21993762
• Report Number: 0001825034-2025-01354
• Device Sequence Number: 17215360
• Product Code: KWS
• UDI-Device Identifier: 00880304677111
• UDI-Public: (01)00880304677111(17)251027(10)853360
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 05/14/2025

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
• Device Expiration Date: 10/27/2025
• Device Catalogue Number: 115399
• Device Lot Number: 853360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 90 KG