MAUDE Adverse Event Report: ZIMMER BIOMET, INC. +3MM LATERAL OFFSET 40MM DIAMETER GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	110030777
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty approximately a little over one (1) month ago.Subsequently, the patient was revised due to infection seventeen (17) days later.Multiple attempts have been made to obtain additional information, but no additional information has been received at this time.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00755.0001822565-2024-00756.0001822565-2024-00757.0001822565-2024-00758.0001822565-2024-00759.0001822565-2024-00760.0001822565-2024-00761.0001822565-2024-00762.0001822565-2024-00763.D10: medical products: item#: unknown, unknown tray; lot#: unknown.Item#: unknown, unknown bearing; lot#: unknown.Item#: unknown, unknown baseplate; lot#: unknown.Item#: unknown, unknown central screw; lot#: unknown.Item#: unknown, unknown peripheral screw; lot#: unknown.Item#: unknown, unknown peripheral screw; lot#: unknown.Item#: unknown, unknown peripheral screw; lot#: unknown.Item#: unknown, unknown peripheral screw; lot#: unknown.Item#: unknown, unknown stem; lot#: unknown.G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, the product was requested but not returned by the hospital.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 information.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.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: +3MM LATERAL OFFSET 40MM DIAMETER GLENOSPHERE
• 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: 18836049
• Report Number: 0001822565-2024-00754
• Device Sequence Number: 7486337
• Product Code: PHX
• UDI-Device Identifier: 00887868231261
• UDI-Public: (01)00887868231261(17)330319(10)65569156
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181611
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 110030777
• Device Lot Number: 65569156
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2023
• 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; Hospitalization
• Patient Sex: Unknown