MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA POSTERIOR REFERENCING SERIES 1 SIZER; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Codes	Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the posterior referencing sizer seems a bit too loose when used on the femur and isn¿t as precise as it should be.Another device was used to complete the surgery.There was no impact on the patient.The surgical technique was utilized.There was no surgical delay.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).G2 : foreign country : canada.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6 evaluation of the returned device exhibits signs of use and the two components rotate a little at each setting.The device is conforming.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.The device specifications were found to be conforming per the functional check and hence no issue was seen with the device.A field communication was released notifying users of appropriate use of the device according to the surgical technique.Upon receiving additional information of the reported event, it was determined to be not reportable as there was no problem found with the device.The initial report should be voided.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.

• Brand Name: PERSONA POSTERIOR REFERENCING SERIES 1 SIZER
• Common Device Name: INSTRUMENT, KNEE
• 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: 19192530
• Report Number: 0001822565-2024-01419
• Device Sequence Number: 15363682
• Product Code: JWH
• UDI-Device Identifier: 00889024632202
• UDI-Public: (01)00889024632202(10)66164958
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221479
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2024

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: 42509904020
• Device Lot Number: 66164958
• 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: 04/06/2024
• Supplement Date Received by Manufacturer: 05/14/2024; 09/25/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/21/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose