MAUDE Adverse Event Report: ZIMMER BIOMET, INC. IDENTITY SHOULDER SYSTEM HUMERAL STEM; EXTREMITY 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	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a 2 week follow up with x-rays, the surgeon discovered a fracture in the lesser tuberosity.The implant has not moved, and it was decided that they would monitor the fracture and implant to see how it progresses.There are no known contributing factors or trauma that occurred.No further information is known.
Additional Manufacturer Narrative
(b)(4).Upon reassessment it was discovered that the reported event of bone fracture is not considered a serious injury as a mild injury, illness, or impairment occurred which does not require prescribed medical treatment.
Event or Problem Description
Upon reassessment it was discovered that the reported event of bone fracture is not considered a serious injury as a mild injury, illness, or impairment occurred which does not require prescribed medical treatment.

• Brand Name: IDENTITY SHOULDER SYSTEM HUMERAL STEM
• Common Device Name: EXTREMITY IMPLANT
• 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: 19679823
• Report Number: 0001822565-2024-02241
• Device Sequence Number: 6964851
• Product Code: HSD
• UDI-Device Identifier: 00889024627055
• UDI-Public: (01)00889024627055(17)330608(10)65970299
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K213856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: SAHS1108
• Device Lot Number: 65970299
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Female