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

Model Number N/A

Device Problems Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2024

Event Type  malfunction  

Event 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.

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 Description

No further event information available at the time of this report.

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.

• Brand Name: PERSONA POSTERIOR REFERENCING SERIES 1 SIZER
• Type of Device: 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
• MDR Text Key: 341381653
• Report Number: 0001822565-2024-01419
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024632202
• UDI-Public: (01)00889024632202(10)66164958
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K221479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/06/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose