MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR HUMERAL HEAD 15 MM HEAD HEIGHT 46 MM SPHERICAL HEAD DIAMETER; SHOULDER, PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure approximately two years post implantation due to dislocation.No further information is available.
Additional Manufacturer Narrative
(b)(4).Report source: foreign: united kingdom.Concomitant medical products: 8mm ã¿ 130mm length humeral stem cat:00434900813 lot: 64188037.Dual taper insert cat:00434903700 lot: 63799290.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Proposed code: mechanical (g04) - head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: MODULAR HUMERAL HEAD 15 MM HEAD HEIGHT 46 MM SPHERICAL HEAD DIAMETER
• Common Device Name: SHOULDER, PROSTHESIS
• 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: 15378310
• Report Number: 0001822565-2022-02569
• Device Sequence Number: 5797367
• Product Code: HSD
• UDI-Device Identifier: 00889024264038
• UDI-Public: (01)00889024264038(17)241231(10)62859933
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 10/05/2022

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00430004615
• Device Lot Number: 62859933
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2014
• 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: Unknown