MAUDE Adverse Event Report: Zimmer Orthopaedic Mfg. Ltd. Persona FEM CR CMT CCR STD SZ 10 L; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous

Catalog Number	42502606801
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) 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
It was reported that the inner package of the femoral box was found dismantled.The sales rep noted that it appeared like it got melted.The device was not used as the surgeon was worried about the sterility of the product.Attempts have been made and all available information has been provided.

• Brand Name: Persona FEM CR CMT CCR STD SZ 10 L
• Common Device Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous
• Manufacturer (Section D): Zimmer Orthopaedic Mfg. Ltd.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): Zimmer Orthopaedic Mfg. Ltd.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50139361
• Report Number: 3007963827-2026-00347
• Device Sequence Number: 13448246
• Product Code: MBH
• UDI-Device Identifier: 00889024230415
• UDI-Public: (01)00889024230415(17)360418(10)67786210
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• 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): 08/05/2026

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: 42502606801
• Device Lot Number: 67786210
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown