MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA CEMENTED ALL-POLY PATELLA 32MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Unspecified Infection (1930); Skin Discoloration (2074); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced cellulitis of the distal incision that extended to the foot within 3 months following left knee arthroplasty.The patient was treated with a twice-daily antibiotic for three (3) weeks, however, continues to experience swelling, discoloration and delayed wound healing.The incision is nearly healed at four (4) months following the procedure, however, the patient stated there was an indication of deep infection.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona stemmed cemented tibial component left size e catalog #: 42532007101 lot #: 66655744, persona posterior stabilized femoral component nitrided left size 8 catalog #: 42570606401 lot #: 65481982, persona posterior stabilized articular surface left 10mm catalog #: 42512400710 lot #: 66562667.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: h4.The reported event of cellulitis could not be confirmed as medical records were not provided.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.The device history records were not reviewed as the event was determined to be unrelated to the implanted device.Sterile certifications were reviewed and found to be conforming with no applicable deviations.The device was verified to have gone through acceptable sterilization processes 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 that may include hospital/surgical environment, provider-related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issue affecting implant safety or effectiveness, the implanted products are not identified as the source or contributing to the reported infection.The root cause was determined to be traced to non-device related factors.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 further event information available at the time of this report.

• Brand Name: PERSONA CEMENTED ALL-POLY PATELLA 32MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21034997
• Report Number: 0002648920-2024-00401
• Device Sequence Number: 9180625
• Product Code: MBH
• UDI-Device Identifier: 00889024247697
• UDI-Public: (01)00889024247697(17)280926(10)66241175
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42540200032
• Device Lot Number: 66241175
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female