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

Catalog Number	110031411
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Common device name: phx.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.Zimmer biomet will continue to monitor for trends.Associated products and reports: 0001822565-2023-00270, item#: 110031425, lot#: 65115634.Other associated products: item#: 110031412, lot#: 64558906; item#: 110031425, lot#: 64833619.
Event or Problem Description
It was reported a patient underwent a reverse total shoulder.During the procedure the implant was noted to be loose, and surgery was completed with different size implant then the one trialed.No serious injury or impact to the patient 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.G2: korea.H6: component code: g03016 tray.Visual examination of the returned products identified the parts show signs of wear and damage.By comparing both prints of the tray and bearing, measurements were taken of the overall height of both as assembled and found to be consistent with the print specifications.Part 110031411: review of the device history record(s) identified no deviations or anomalies during manufacturing.Upon conclusion of the investigation, no problem was found with the given devices.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 TI +3 OFFSET
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 16303600
• Report Number: 0001822565-2023-00272
• Device Sequence Number: 6792117
• Product Code: PHX
• UDI-Device Identifier: 00887868231438
• UDI-Public: (01)00887868231438(17)320531(10)65386114
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110031411
• Device Lot Number: 65386114
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10.
• Patient Sex: Unknown