MAUDE Adverse Event Report: Zimmer Orthopaedic Mfg. Ltd. PSN PK CMT FEM LM SZ 3; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Catalog Number	42558000301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a clinical study that at the two-year follow-up visit a patient reported experiencing increased pain and dissatisfaction.Home strengthening exercises were recommended as well as over the counter medication for pain.All implants remain intact, and no further information has been provided at this time.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
(b)(4) d10-medical product psn pk ve ply lm sz c 9mm item# 42518200309 lot# 63441805 psn pk cmt tib lm sz c item# 42538000301 lot# 63573649 unknown palacos cement h3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H6: component code: proposed component (annex g) code is: - mechanical (g04) - femur.

• Brand Name: PSN PK CMT FEM LM SZ 3
• Common Device Name: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, 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 Biomet, Inc.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50174757
• Report Number: 3007963827-2026-00354
• Device Sequence Number: 18231291
• Product Code: HSX
• UDI-Device Identifier: 00880304808461
• UDI-Public: (01)00880304808461(17)270228(10)63607286
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: 42558000301
• Device Lot Number: 63607286
• 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: 07/23/2026
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 264 LB