MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MC VE ASF R 10MM 8-11/EF; PROSTHESIS, KNEE

Catalog Number	42522100810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: tibia trabecular metal two-peg porous fixed bearing right size f: catalog#42530007502, lot#66974226; femur trabecular metal cruciate retaining (cr) standard porous: catalog#42502806602, lot#66704666; nexgenâ® complete knee solution, trabecular metalâ¿¢ standard primary patella: catalog#00587806532, lot#66053884.G2: foreign: australia.Visual examination of the provided picture identified a used articular surface with visible traces of blood.Device history record was reviewed and no discrepancies related to the reported event were found.X-rays were provided and reviewed by a third party.Imaging analysis states that the right knee arthroplasty is anatomically aligned with no evidence of implant loosening, wear, radiolucency, or malalignment.Surgical screws are present at the proximal tibia.Bone quality appears osteopenic.No anatomical or implant failures were identified that would lead to revision.Regarding the reported infection, investigation results concluded that the root cause of the reported event is attributed to non-device related factors as the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.Regarding the reported fall and instability, root cause was unable to be determined.Reported event was unable to be confirmed.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
It was reported that a patient underwent an initial total knee arthroplasty.Approximately four (4) weeks post-implantation, the patient underwent a debridement and articular surface exchange due to infection.It was also noted that the patient had a known fall one (1) week post-implantation and the surgeon upsized the bearing as the knee was a little loose in flexion.It was reported that all available information has been provided.

• Brand Name: PERSONA MC VE ASF R 10MM 8-11/EF
• 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: 22784883
• Report Number: 3007963827-2025-00319
• Device Sequence Number: 15963968
• Product Code: MBH
• UDI-Device Identifier: 00889024468412
• UDI-Public: (01)00889024468412(17)291209(10)67052146
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 08/12/2025

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: Lay User/Patient
• Device Catalogue Number: 42522100810
• Device Lot Number: 67052146
• 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: 07/15/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male