MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI TRAY STD COCR +3 OFFSET; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	110031402
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00787.Concomitant medical products: item#: 110031421, cr prolong 40mm brng std; lot#: 65369975.Item#: 00436004000, glenosphere centric 40 mm diameter +0 mm lateral offset; lot#: 65473796.Report source: foreign: canada.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 a revision left shoulder arthroplasty approximately three (3) months due to the implants disassociating.No additional information is available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00787-1.Surface damage is seen on the inner humeral tray.Dimensional analysis was not performed due to damage.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: the 3rd image series demonstrates complete joint space loss between the inferior margin of the glenosphere and humeral tray.This is a secondary finding which suggests that the polyethylene lining may be compromised.This suggestion is confirmed on the ct image which demonstrates a reverse c-shaped radiolucent structure superior to the scapula which is consistent with polyethylene displacement.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.

• Brand Name: MINI TRAY STD COCR +3 OFFSET
• 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: 16590093
• Report Number: 0001822565-2023-00786
• Device Sequence Number: 12034233
• Product Code: PHX
• UDI-Device Identifier: 00887868231346
• UDI-Public: (01)00887868231346(17)310808(10)65171129
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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 Model Number: 110031402
• Device Catalogue Number: 110031402
• Device Lot Number: 65171129
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male