MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP AUG MINI BSPLT W TPR MD; PROSTHESIS, SHOULDER

Catalog Number	110032420
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Procode: phx.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
It was reported that a patient underwent a revision approximately 1 month postimplantation due to a baseplate/taper disassociation which caused a displaced glenosphere and secondary damage to the humeral bearing.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.Visual examination of the taper of the taper adapter does not show any signs of damage but does show signs of use.The item and lot numbers of the taper adapter are confirmed to match the complaint.No product was returned or pictures provided for the baseplate as it remains implanted; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left reverse total shoulder arthroplasty with dissociation of the glenosphere from the glenoid base plate now with dislocated glenosphere within the superior aspect of the joint space.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: op report and post-op imaging notes showed postop changes from a reverse shoulder arthroplasty.After use of general anesthesia with interscalene block, a small amount of fibrous tissue was removed.The loosened glenosphere and humeral tray were removed.Glenosphere was reimpacted after changing the central screw size.Surgeon notes ¿it was felt as though this corrected the reason for failure of the original implant.¿ radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the left shoulder demonstrate reverse total shoulder arthroplasty with intact glenoid plate.Separation of the glenosphere from the glenoid plate with dislocated glenosphere within the superior aspect of the joint space.Humeral component is intact.As it was confirmed that the screw guide/template was used to check that the central screw was fully seated during the initial surgery, it remains that 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: COMP AUG MINI BSPLT W TPR MD
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13656352
• Report Number: 0001825034-2022-00418
• Device Sequence Number: 5275641
• Product Code: PHX
• UDI-Device Identifier: 00880304993242
• UDI-Public: (01)00880304993242(17)260816(10)65212354
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K172502
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/29/2022

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 Expiration Date: 08/16/2026
• Device Catalogue Number: 110032420
• Device Lot Number: 65212354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• 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: 02/21/2022
• Supplement Date Received by Manufacturer: 05/25/2022; 08/24/2022; 09/13/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/26/2022; 09/01/2022; 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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 Sex: Male