MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MC VE ASF L 11MM 6-7/EF; PROSTHESIS, KNEE

Catalog Number	42512100711
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Fever (1858); Pain (1994); Confusion/ Disorientation (2553); Swelling/ Edema (4577); Medical device site infection (4845)
Date of Event	10/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown - unknown femoral component - unknown.Unknown - unknown tibial component - unknown.G2: foreign country: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial left knee surgery.Approximately 6 weeks post-op, the patient was experiencing pain, lower leg pitting and edema, cellulitis, fever, and confusion.Subsequently, the patient was revised due to infection.The poly was revised.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h4; h6.The event cannot be confirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the reported event by a health care professional found that cellulitis is a rapid-spreading bacterial infection of the dermis and subcutaneous tissues, often caused by normal skin flora or opportunistic residential bacteria, such as streptococcus pathogens.Cellulitis appears as localized redness, swelling, and rash that is hot and painful to touch.The bacteria enter the skin via any cut, abrasion, or break in the skin, thus placing postoperative joint patients at increased risk for the development of cellulitis.Other comorbidities that increase the risk for post operative development of cellulitis include smoking, diabetes, poor nutrition, obesity, poor hygiene, or circulatory problems.Cellulitis may be resolved on its own with conservative treatment but most often requires additional medical intervention, such as oral or intravenous antibiotics, to eradicate the infection.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.The root cause of the reported event was determined to be unrelated to the device.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 further event information available at the time of this report.

• Brand Name: PERSONA MC VE ASF L 11MM 6-7/EF
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23452841
• Report Number: 3007963827-2025-00433
• Device Sequence Number: 15540002
• Product Code: MBH
• UDI-Device Identifier: 00889024469228
• UDI-Public: (01)00889024469228(17)300114(10)67109289
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42512100711
• Device Lot Number: 67109289
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Unknown