MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 4MM MICRO; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES

Catalog Number	113604
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested from the hospital but not returned.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 the patient underwent an initial shoulder arthroplasty approximately one (1) month ago.Subsequently, the patient underwent a revision surgery seven (7) days later due to improper placement of the humeral stem.Attempts have been made to obtain additional information.No additional information has been received at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.H6: component codes: mechanical (g04)-stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.It was indicated that there was a malunion of the patient's humerus indicating the bone was not in anatomical alignment.As such the patient's anatomy was determined to be causing the reported issue.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 4MM MICRO
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES
• 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: 20916859
• Report Number: 0001825034-2024-02932
• Device Sequence Number: 8285861
• Product Code: MBF
• UDI-Device Identifier: 00880304554054
• UDI-Public: (01)00880304554054(17)280925(10)486400
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193038
• 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): 03/11/2025

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 Catalogue Number: 113604
• Device Lot Number: 486400
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2018
• 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: Male