MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN MC VE ASF L 10MM 8-11/EF; PROSTHESIS, KNEE

Catalog Number	42512100810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a study that approximately 1 month post implantation of a left total knee arthroplasty, the patient was diagnosed with cellulitis and was prescribed antibiotics, as well as underwent a wound debridement, irrigation, and wound care.The patient was reported as fully healed approximately 6 weeks later.Devices remain implanted.Attempts were made and all available information was provided.
Additional Manufacturer Narrative
(b)(4).D10: 42508606801, psn fem cr pps ccr std sz10 l, lot 66892157.42536007501, psn tib np 0 deg kel f lt, lot 66994339.42540000035, psn all poly pat ply 35mm, lot 66948873.00111314001, palacos rg 1x40 single, 70851425.Customer 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated:.The root cause of the reported event is not considered device related.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 resolve on its own with conservative treatment but most often requires additional medical intervention, such as oral or intravenous antibiotics, to eradicate the infection.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information to report.

• Brand Name: PSN MC VE ASF L 10MM 8-11/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 BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22668498
• Report Number: 3007963827-2025-00298
• Device Sequence Number: 11691449
• Product Code: MBH
• UDI-Device Identifier: 00889024469297
• UDI-Public: (01)00889024469297(17)291104(10)66991237
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 42512100810
• Device Lot Number: 66991237
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White