MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA CEMENTED ALL-POLY PATELLA 41MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Ecchymosis (1818); Hematoma (1884); Pain (1994); Muscle/Tendon Damage (4532); Joint effusion (4849)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona posterior stabilized cemented standard femoral component right size 11 catalog #: 42500607002 lot #: 64520139, persona cemented keel tibial component size g catalog #: 42536007902 lot #: 65818886, persona posterior stabilized articular surface right 10mm catalog #: 42522401010 lot #: 65930324.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 that the patient underwent an irrigation and debridement procedure approximately two (2) weeks following right knee arthroplasty to address wound dehiscence accompanied by ecchymosis and moderate effusion as well as repair the patient's quadricep tendon.During the procedure, a subcutaneous hematoma was evacuated and the vastus medialis was closed with one loop.No implants were removed.Initial operative notes noted no intraoperative complications.Irrigation and debridement operative notes noted no intraoperative complications.
Event or Problem Description
No further event information available at the time of this report.
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; h10.Product has not been evaluated as it has been determined the event is not related to device.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression ''wound concerns'' or ''non-healing wound'' would imply that the appearance of the wound deviates from what a surgical wound should appear.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.This deviation signifies an alteration in the wound healing process which can be complicated by patient comorbidities such as diabetes, obesity, smoking, and other conditions that are known to slow a person¿s ability to heal.Wound complications can be treated conservatively or more invasively with an irrigation and debridement (i&d) which promotes healing at the site and prevents further complications.If deeper exploration of the wound is warranted and the joint space is entered, a poly exchange is typically performed in conjunction with the i&d to clear out any debris, hematoma formation, or to prevent deep joint infection.The root cause of the reported event is not device related.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.

• Brand Name: PERSONA CEMENTED ALL-POLY PATELLA 41MM
• 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 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: 21366036
• Report Number: 0002648920-2025-00040
• Device Sequence Number: 20945518
• Product Code: MBH
• UDI-Device Identifier: 00889024247727
• UDI-Public: (01)00889024247727(17)280610(10)66093369
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: 42540200041
• Device Lot Number: 66093369
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White