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

Model Number	N/A
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon noticed motion in top portion of the device while sizing the femur with device.Attempts to obtain additional information have been made.However, no more is available.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: 2.5 mm female hex screw 25 mm length catalog # 42509902525 lot # 66654609.All-poly patella catalog # 42540200035 lot # 66723250.0â° spiked keel right size e osseoti tibia catalog # 42535007102 lot # 66339500.Articular surface catalog # 42522100810 lot # 65831951.Femur trabecular metal cruciate retaining (cr) standard porous catalog # 42502806402 lot # 66545040.Articular surface medial congruent (mc) right 10 mm height use with tibia sizes e-f/cr femur sizes 8-11 catalog # 42522100810 lot # 66688618.Headless trocar drill pin 3.2 mm diameter 75 mm length catalog # 00590102000 lot # 66712923.H3: the complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g4, g7, h1, h2, h3, h4, h6, h9, h10.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of use and confirmed there is slight play.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.No problem found with returned device.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: PERSONA POSTERIOR REFERENCING SIZER
• Common Device Name: KNEE INSTRUMENT
• 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: 20566546
• Report Number: 0001822565-2024-03422
• Device Sequence Number: 7827242
• Product Code: JWH
• UDI-Device Identifier: 00889024632202
• UDI-Public: (01)00889024632202(11)220812(10)ZB7251988
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 42509904020
• Device Lot Number: ZB7251988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose