MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 25MM VERSA-DIAL TAPER ADAPTOR; PROSTHESIS, SHOULDER

Catalog Number	118000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Common device name: phx.Concomitant medical products: comp rvrs 25mm bsplt ha+adptr cat# 010000589 lot# 216000.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple medwatches are associated with this event, please see associated reports: 0001825034 - 2022 - 01428.
Event or Problem Description
It was reported that a patient is being considered for a revision due to disassociation.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 4 months post implantation due to disassociation.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b2, b3, b4, b5, d6b, g3, g6, h2, h6, h10.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) 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: both of the images demonstrate disassociation of the glenosphere which is separated from the base plate and located lateral and anterior to the humeral head.The remainder of the hardware is intact.No periprosthetic lucencies.No acute bone or hardware fracture.Chronic fracture of the acetabulum and possible chronic fracture of the distal clavicle.It is unknown whether the provided x-rays were taken prior to the first or second revision.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 is available at the time of this report.

• Brand Name: 25MM VERSA-DIAL TAPER ADAPTOR
• 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: 14830803
• Report Number: 0001825034-2022-01429
• Device Sequence Number: 11970091
• Product Code: PHX
• UDI-Device Identifier: 00880304531048
• UDI-Public: (01)00880304531048(17)301013(10)055440
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K120121
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2022

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: 118000
• Device Lot Number: 055440
• 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: 06/06/2022
• Supplement Date Received by Manufacturer: 06/27/2022; 07/29/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 06/29/2022; 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Female