MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEM CR PPS CCR STD SZ4 L; PROSTHESIS, KNEE

Catalog Number	42508605601
Medical Device Problem Codes	Positioning Failure (1158); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that femur component did not achieve press fit and was loose during procedure.The femur was removed and a new femur was utilized.The surgical technique was utilized.No pieces fell inside the patient.The implant was switched to a cemented femur that added about 15 to 20 minutes to the surgical procedure.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42502705601 - cr femoral provisional left size 4 - 62820406.H6: mechanical (g04) - femur.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.

• Brand Name: PERSONA FEM CR PPS CCR STD SZ4 L
• Common Device Name: PROSTHESIS, 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: 25167196
• Report Number: 0001822565-2026-01565
• Device Sequence Number: 18797571
• Product Code: JWH
• UDI-Device Identifier: 00889024631236
• UDI-Public: (01)00889024631236(17)340614(10)66626461
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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 Catalogue Number: 42508605601
• Device Lot Number: 66626461
• 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: 04/24/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• 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 H11.
• Patient Sex: Unknown