MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 11; PROSTHESIS, KNEE

Catalog Number	42502607001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fluid Discharge (2686)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 1 patient in the conventional group experienced postop wound leakage leading to prolonged hospital stay of 1 day.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).B3 year published: 2022, 2024.D10: tibia cemented, #item 42532007901, #lot 65546752.Articular surface fixed bearing, #item 42511000610, #lot 65539533.Femur cemented, # item 42502607001, #lot 65571883.Therapy date: unknown.G2: foreign - event occurred in netherlands.G2: literature - eijking, h.M., hendrickx, r., van haaren, e.H., schotanus, m.G.M., dorling, i., bouwman, l., boonen, b., most, j.(2026).Robotic-assisted inverse kinematic aligned vs conventional mechanical aligned total knee arthroplasty.Unpublished manuscript.The event was initially reported under (b)(4).The cmp was not confirmed.Review of the reported event by a health care professional found: it is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 invasively depending on the severity of the wound infection and patient status.No product was returned or pictures provided visual and dimensional evaluations could not be performed.The root cause of the reported event was determined to be unrelated to the device.This is a limited investigation; a review of the device history record and complaint history review will not be completed for limited investigation complaints as the product meets the applicable acceptance criteria.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.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.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 11
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• 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: 25163391
• Report Number: 3007963827-2026-00191
• Device Sequence Number: 18825677
• Product Code: MBH
• UDI-Device Identifier: 00889024230439
• UDI-Public: (01)00889024230439(17)330107(10)65571883
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: 42502607001
• Device Lot Number: 65571883
• 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: 04/20/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Male