MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SIZER HANDLE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: canada.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported that during surgery that the glenoid sizing handle doesn¿t hold the sizer.Photograph of the device indicates that it is fractured.There was no harm, injury, surgical/medical intervention to patient and no record of a delay.Due diligence is in progress.No additional information is available at this time.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error.
Event or Problem Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided.The device was not fractured but was only bent.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, d4, d9, g1, g3, g6, h2, h3, h4, h6, h11.Due diligence with the reporting contact confirmed that the device was not fractured and that only the prongs were bent.However, once product was returned and evaluated, it was determined that the plunger was fractured and not returned.Therefore, 0001822565-2025-00040-1 should be disregarded and the event is reportable.Visual examination of the returned product identified the plunger of the device has fractured and was not returned.Fracture analysis has been previously analyzed for this fracture location where overload was identified as the mode of failure.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.The reported event has been confirmed through product return.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Upon evaluation of the returned device, it was observed that the plunger of the device was fractured.

• Brand Name: SIZER HANDLE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 21081311
• Report Number: 0001822565-2025-00040
• Device Sequence Number: 6899210
• Product Code: KWS
• UDI-Device Identifier: 00889024574632
• UDI-Public: (01)00889024574632(10)65636161
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SBGL2000
• Device Lot Number: 65636161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 03/14/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/21/2025; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose