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

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	06/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: femur cemented cruciate retaining (cr) narrow right size 7 catalog # 42502006202 lot # 65872709.All-poly patella cemented 29 mm diameter catalog # 42540200029 lot # 65963394.Articular surface medial congruent (mc) right 11 mm height use with tibia sizes c-d/cr femur sizes 6-7 catalog # 42522100411 lot # 65618468.Palacos r + g (1x40) catalog # 66022663 lot # 65301168.G2: australia.H3: customer has indicated that the product will not be returned because requested but not returned by hospital.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent a revision procedure ten months post implantation due to tibial loosening after sustaining a fall and injuring in right knee.No more information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h1, h2, h3, h6, h11.Reported event was confirmed by review of medical records provided.Visual examination of the provided pictures identified the tibial plate involved in the reported event but could not be used to confirm the complaint.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates that this event is for tibial loosening after fall for unknown reason and is considered a serious injury as, illness or impairment which hospitalisation, medical intervention and/or surgical intervention has occurred.Patient sustained a fall injuring her right knee cause of fall unknown and the have ongoing pain.Bone scan showed increased perfusion, and blood pool in proximal right tibia adjacent to the tibial component, increased periprosthetic tibial component osteoblastic activity, no overt fracture or displacement.Right tibial component bone injury or loosening shown on ct scan.Review of the radiographs identified: ap view of the right knee demonstrates normal arthroplasty alignment and no evidence of implant loosening.Bone scan images demonstrate abnormal uptake along the tibial implant consistent with implant loosening and no evidence of femoral implant loosening.Overall impressions: normal radiographic appearance of the right knee arthroplasty with bone scan findings consistent with tibial implant loosening.If any further information is found which would change or alter any conclusions or information, a supplemental 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 TIBIA CEMENTED DEGREE STEMMED
• 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: 19755473
• Report Number: 3007963827-2024-00276
• Device Sequence Number: 6491579
• Product Code: MBH
• UDI-Device Identifier: 00889024246683
• UDI-Public: (01)00889024246683(17)330627(10)66021368
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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 Model Number: N/A
• Device Catalogue Number: 42532006702
• Device Lot Number: 66021368
• 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: 06/30/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 75 KG