MAUDE Adverse Event Report: Zimmer Orthopaedic Mfg. Ltd. PSN MC VE ASF R 10MM 8-11/GH; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Catalog Number	42522100910
Medical Device Problem Codes	Fracture (1260); Peeled/Delaminated (1454); Pitted (1460)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient has had ongoing stiffness, pain, and decreased range of motion.The patient is now twelve months post total knee replacement.An arthroscopic procedure was done, and the surgeon noted synovitis, poly pitting, edge cracking and delamination.The articular surface has not been removed.There is no additional information available.
Additional Manufacturer Narrative
(b)(4).D10- medical product femur trabecular metal (cr) standard porous item# 42502807002 lot# 66790177, tibia cemented 5 degree stemmed right size g item# 42532007902 lot# 67162598, all-poly patella cemented 35 mm diameter item# 42540200035 lot# 67158221.G2- australia.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.

• Brand Name: PSN MC VE ASF R 10MM 8-11/GH
• 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 ; +1(574)526-0384
• MDR Report Key: 50157154
• Report Number: 3007963827-2026-00350
• Device Sequence Number: 10607248
• Product Code: MBH
• UDI-Device Identifier: 00889024468498
• UDI-Public: (01)00889024468498(17)300208(10)67145339
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 42522100910
• Device Lot Number: 67145339
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2026
• 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: 07/22/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 258 LB