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

Catalog Number	118000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left shoulder arthroplasty approximately six (6) weeks ago.Subsequently, the patient was seen by their surgeon three (3) weeks later and it was discovered that the implants had disassociated.The patient underwent a revision surgery approximately three weeks ago.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 110027734, compr vrs glen pps min tpr adr; lot#: 66573916.Item#: 110030776, cr 40mm glenosphere std cocr; lot#: 65398246.H3: 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were corrected: a3; d4.Visual examination of the returned product/provided pictures identified one 25mm versa-dial taper adaptor item# 118000 lot#j7614800 was returned and evaluated.Upon visual inspection the taper adapter there are galling to post.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: there is a reverse-type left shoulder arthroplasty.The glenosphere is disassociated and displaced from the glenoid baseplate and the proximal humerus is anterosuperiorly subluxed/dislocated in relation to the glenoid.Operative change is noted at the acromioclavicular joint and there is regional heterotopic ossification.There is no fracture or evidence of implant loosening.Bone quality is osteopenic.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: 25MM VERSA-DIAL TAPER ADAPTOR
• Common Device Name: COMPREHENSIVE SHOULDER SYSTEM MINI TAPER ADAPTOR
• 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: 19132990
• Report Number: 0001825034-2024-01047
• Device Sequence Number: 17300980
• Product Code: PHX
• UDI-Device Identifier: 00880304531048
• UDI-Public: (01)00880304531048(17)331005(10)J7614800
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: J7614800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• 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: 03/22/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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; Other
• Patient Sex: Male