MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD.; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).B3 year published: 2022, 2024.D10: pn: 42532006701 ln: 66459189 tibia cemented 5 degree stemmed left size d.Pn: 42502006401 ln: 66196359 femur cemented cruciate retaining (cr) narrow left size 8.G2 foreign: the netherlands.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Unpublished manuscript.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Was initially reported under 0001822565-2026-00277.
Event or Problem Description
It was in a journal article that patient required wound excision approximately 4 months post implantation.Attempts to obtain additional information have been made; however, no more is available at this time.

• Common Device Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
• 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: 25162503
• Report Number: 3007963827-2026-00188
• Device Sequence Number: 8634365
• Product Code: MBH
• UDI-Device Identifier: 00889024640054
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2026

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female