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

Catalog Number	42532007102
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Ambulation or Postural Difficulties (2544)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right knee procedure.Subsequently, synovitis was noted and cultures were performed and the patient was revised approximately 1.5 years post-op due to instability and aseptic loosening.All components were revised.It was noted that there was no cement on the tibial implant or on the bone.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10 : 42522100810 - articular surface medial congruent (mc) right 10 mm height use with tibia sizes e-f/cr femur sizes 8-11 - 66179313 42502606402 - femur cemented cruciate retaining (cr) standard right size 8 - 65375686.G2 : foreign country : switzerland.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.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h4; h6.The event cannot be confirmed.Visual examination of the provided pictures identified a tibial baseplate implant in situ in the first image.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a healthcare professional.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 TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E
• 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: 21432487
• Report Number: 3007963827-2025-00066
• Device Sequence Number: 14623715
• Product Code: MBH
• UDI-Device Identifier: 00889024471061
• UDI-Public: (01)00889024471061(17)331009(10)66179313
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 06/17/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42532007102
• Device Lot Number: 66179313
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 77 KG