MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 4 X 194 REV; EXTREMILTY IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient dislocated one day after the primary surgery.Upon revising, it was noted that the proximal humerus had fractured, causing the uncemented stem to destabilise move distally, creating instability in the joint construct.The patient prior to primary procedure had significant bilateral bone loss on both the glenoid and proximal humerus.Custom glenoid was required, and fracture stem used.No further information is known.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 110031428, +3mm thickness 40mm diameter bearing, lot # 65592541.Catalog #: 110031399, mini standard thickness +0mm taper offset 40mm diameter humeral tray, lot # 66421181.Catalog #: 12-113558, compr 8mm hum fract stem pps, lot # 65758088.G2: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been 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).Proposed component code: mechanical (g04) stem.Updated: b4, b5, d2, g3, h1, h2, h3, h6, h11.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP PRIMARY STEM 4 X 194 REV
• Common Device Name: EXTREMILTY IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20521990
• Report Number: 0001825034-2024-02510
• Device Sequence Number: 9171009
• Product Code: HSD
• UDI-Device Identifier: 00880304462540
• UDI-Public: (01)00880304462540(17)290206(10)944380
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060692
• 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): 11/11/2024

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 Model Number: N/A
• Device Catalogue Number: 113664
• Device Lot Number: 944380
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2019
• 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: Female