MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING; 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); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a left total knee arthroplasty.Subsequently, the patient is now experiencing pain, swelling, stiffness, feeling of legs starting to give out, and is currently walking with crutches.At this time, no surgical intervention has been reported.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10 : 42500606601 - femur cemented posterior stabilized (ps) standard left size 9 - 62958250.42532008301 - tibia cemented 5 degree stemmed left size h - 62770833.42557000114 - stem extension tapered cemented 14 mm diameter +30 mm length - 63129501.42540000035 - all poly patella cemented 35 mm diameter - 62969317.Unknown - unknown palacos cement - unknown.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: 42500606801 - femur cemented posterior stabilized (ps) standard left size 10 - 62958250.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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.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.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Office notes provided state that patient had pain, swelling, stiffness, and walked with help of crutches.Instability exam was restricted due to pain.X-rays review at office visit found the knee to be in good position without evidence of loosening or wear.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING
• 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: 19911734
• Report Number: 3007963827-2024-00303
• Device Sequence Number: 18343689
• Product Code: MBH
• UDI-Device Identifier: 00889024238312
• UDI-Public: (01)00889024238312(17)250131(10)64645238
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2025

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 Expiration Date: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 42512601016
• Device Lot Number: 64645238
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 08/21/2024; 01/03/2025
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 08/27/2024; 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2020
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 127 KG