MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE HUMERAL FRACTURE STEM; PROSTHESIS, SHOULDER

Model Number	12-113556
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fracture, Arm (2351)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
Event or Problem Description
It was reported the patient is scheduled for an upcoming revision to address humeral bone fracture secondary to a patient fall unrelated to the prosthesis.No further information is available at this time.
Event or Problem Description
Upon reassessment of the reported event, the stem was determined to be not reportable.As the humerus fractured due to the patient falling, the humeral stem did not fail or fracture, and the device or procedure did not cause or contribute to the fall (the patient does not bear weight on the arm to stand/walk).The surgeon also indicated that the fall was not due to the prosthesis; therefore, this complaint is not reportable.
Additional Manufacturer Narrative
Upon reassessment of the reported event, the stem was determined to be not reportable.As the humerus fractured due to the patient falling, the humeral stem did not fail or fracture, and the device or procedure did not cause or contribute to the fall (the patient does not bear weight on the arm to stand/walk).The surgeon also indicated that the fall was not due to the prosthesis; therefore, this complaint is not reportable.

• Brand Name: COMPREHENSIVE HUMERAL FRACTURE STEM
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9591095
• Report Number: 0001825034-2020-00263
• Device Sequence Number: 18947247
• Product Code: KWS
• UDI-Device Identifier: 00880304591530
• UDI-Public: 00880304591530
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2020

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 Expiration Date: 06/18/2026
• Device Model Number: 12-113556
• Device Catalogue Number: 12-113556
• Device Lot Number: 151090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other