MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING (PS); PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Ambulation or Postural Difficulties (2544); Hyperextension (4523); Joint Laxity (4526); Joint effusion (4849)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee surgery and approximately 2 years post-op, they are experiencing hyperextension and instability.The onset of symptoms was unknown as it was gradual and intermittent.The patient noted a fall without injury as the knee gave out.The patient currently walks with crutches and wears a knee brace.The patient has seen several surgeons for their symptoms, one of which thinks the femoral component may be too small.Another surgeon thought the issue could be attributed to the patient's spinal history.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42500606402 - femur cemented posterior stabilized (ps) standard right size 8 - 63066185.42532007902 - tibia cemented 5 degree stemmed right size g - 63118302.42557000114 - stem extension tapered cemented 14 mm diameter +30 mm length - 63171869.42540000035 - all poly patella cemented 35 mm diameter - 63049967.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10 : unknown - unknown cement - unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported a patient underwent a knee surgery and subsequently began to experience pain, hyperextension, and instability.The patient then experienced a fall without injury after his knee gave out and is currently walking with crutches and a knee brace.The patient has consulted with several surgeons with recommendations for a revision.No revision is currently planned as the patient is seeking the best route before proceeding.All available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b2; b3; b4; b5; d2; d6b; e1;g1; g3; g6; h1; h2; h6.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was further reported that the patient was revised due to pain, instability, and hyperflexion.The patient was revised to a hinge knee.The surgeon noted that a mc poly was used with a ps femur by the previous surgeon.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 event is confirmed.Visual examination of the provided picture identified explanted orthopedic components, including a polyethylene insert and a femoral component.The polyethylene insert shows a visible fracture of the spine.The device history record was reviewed and no discrepancies relevant to the reported event were found.Operative notes provided and reviewed state that the patient reported recurring symptoms of hyperextension, instability resulting in a non traumatic fall, and a gradual, intermittent onset of pain.Contributing factors, including the patient¿s significant spinal pathology, posture issues, and obesity, may exacerbate knee hyperextension.Multiple medical evaluations were performed and the patient was revised.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 ARTICULAR SURFACE FIXED BEARING (PS)
• 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: 19705096
• Report Number: 3007963827-2024-00263
• Device Sequence Number: 15400049
• Product Code: MBH
• UDI-Device Identifier: 00889024243965
• UDI-Public: (01)00889024243965(17)250531(10)64618006
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/06/2025

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: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 42522400916
• Device Lot Number: 64618006
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 07/18/2024; 12/09/2024; 01/24/2025
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/30/2024; 12/16/2024; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• 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 H10.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Male
• Patient Weight: 127 KG