MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA TIBIA CEMENTED 5 DEGREE STEMMED LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42572005801 - femur cemented cruciate retaining (cr) narrow nitrided left size 5 - 65475953.42512100311 - articular surface medial congruent (mc) left 11 mm height use with tibia sizes c-d/cr femur sizes 4-5 - 64557822.42540200032 - all-poly patella cemented 32 mm diameter - 65499703.5087347 - palacos mv 1x40 us - 97971054.5087347 - palacos mv 1x40 us - 97971054.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported a patient had an initial left total knee arthroplasty followed by a post-operative deep vein thrombosis and pulmonary embolism.Subsequently, at the two year follow-up, the patient reported increasing knee pain with tightness and spasms.The patient was prescribed physical therapy and instructed to monitor water and electrolyte intake.All implants remain in place and if the symptoms persist, will consider a further evaluation.Attempts have been made and all available information has been provided.
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; h6; h10.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Operative notes provided and reviewed state that a patient underwent a left total knee arthroplasty, followed by post-operative deep vein thrombosis and pulmonary embolism.At the two-year follow-up, the patient reported increasing knee pain with tightness and spasms, particularly at night, which had been present intermittently for several months.The symptoms were noted after increased physical activity, and clinical findings included mild effusion, tenderness along the medial joint line, and a range of motion (rom) of 0-120.X-rays indicated a well-fixed and well-aligned prosthesis with no evidence of implant failure, and the physician attributed the symptoms to possible deconditioning rather than implant-related issues.The patient was prescribed physical therapy and advised to monitor water and electrolyte intake, with further evaluation to be considered if symptoms persist.A definitive root cause cannot be determined.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 TIBIA CEMENTED 5 DEGREE STEMMED LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• 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: 20517412
• Report Number: 3007963827-2024-00416
• Device Sequence Number: 12692448
• Product Code: MBH
• UDI-Device Identifier: 00889024471016
• UDI-Public: (01)00889024471016(17)310822(10)65121343
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/03/2025

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: 42532006401
• Device Lot Number: 65121343
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White