MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA POSTERIOR STABILIZED CEMENTED STANDARD FEMORAL COMPONENT RIGHT SIZE 9; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2 - report source - foreign: event occurred in china.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 during knee arthroplasty that upon opening the femoral implant, the sterile packaging was identified to be damaged.The prosthesis was sterilized and soaked in iodine povidone and used to complete the procedure.The patient has not experienced any complications to date and no adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under cmp-(b)(4).Visual evaluation of the provided photos found the sterile packaging exhibits damage that is visually consistent with thermal damage.Additionally, it has been reported the device was soaked in iodine povidone due to the immediate need to complete the procedure, and was then implanted in the patient.Review of the device history records identified no deviations or anomalies during manufacturing not related to the reported event.A definitive root cause of the damaged packaging cannot be determined.This complaint was confirmed by evaluation of the provided photos.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
No additional information is available regarding the incident.

• Brand Name: PERSONA POSTERIOR STABILIZED CEMENTED STANDARD FEMORAL COMPONENT RIGHT SIZE 9
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• 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 ; 5745260384
• MDR Report Key: 20652463
• Report Number: 3007963827-2024-00446
• Device Sequence Number: 12432675
• Product Code: JWH
• UDI-Device Identifier: 00889024229266
• UDI-Public: (01)00889024229266(17)320625(10)65391611
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/21/2025

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: 42500606602
• Device Lot Number: 65391611
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2022
• 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