MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PK VE PLY RM SZ E 8MM; PROSTHESIS, KNEE

Catalog Number	42528200508
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial partial knee arthroplasty, foreign material resembling a human hair was observed upon opening of the device packaging.There was no patient impact and no adverse events have been reported as a result of the malfunction.A secondary device was used to complete the procedure without further complication.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in japan.The 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d6a; d9; g3; h2; h3; h6; h11.Visual evaluation of the provided photos could not identify the reported hair-like debris; however, there is a hair-like debris that was taped to the inside of the returned blister.As the packaging has been previously opened, the source of the debris cannot be determined.Complaint sample was evaluated, and the reported event was confirmed.Analytical testing found the debris is most consistent with hair.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.
Event or Problem Description
It was reported that during an initial partial knee arthroplasty, foreign material resembling a human hair was observed upon opening of the device packaging.The device was implanted however there was no patient impact and no adverse events have been reported as a result of the malfunction.

• Brand Name: PERSONA PK VE PLY RM SZ E 8MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23830038
• Report Number: 0001825034-2025-04036
• Device Sequence Number: 9278000
• Product Code: HSX
• UDI-Device Identifier: 00880304818231
• UDI-Public: (01)00880304818231(17)300407(10)67248001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: 42528200508
• Device Lot Number: 67248001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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