MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SIZE 8 MICRO HUMERAL STEM; PROSTHESIS, SHOULDER

Catalog Number	SAHS1208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right shoulder was revised after a month of initial implantation due to a periprosthetic fracture.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).D10: cat: sahtnem6 lot: 66705902 -6mm extended neutral humeral tray; cat: 110031424 lot: 66515113 standard 36mm diameter bearing.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device 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.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g3, g6, h1, h2, h3, h6, h11 the following section was corrected: h4 proposed code: mechanical (g04)- stem reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device is used for treatment.Device history record (dhr) 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 is available at the time of this report.

• Brand Name: SIZE 8 MICRO HUMERAL STEM
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 19546918
• Report Number: 0001822565-2024-02002
• Device Sequence Number: 17844108
• Product Code: KWS
• UDI-Device Identifier: 00889024627222
• UDI-Public: (01)00889024627222(17)330505(10)65988703
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K213856
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: SAHS1208
• Device Lot Number: 65988703
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 51 KG