MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CEMENTED CRUCIATE RETAINING STANDARD FEMORAL COMPONENT LEFT SIZE 10; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address aseptic femoral loosening and suspected polyethylene failure approximately six (6) years post-operatively.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona ultracongruent articular surface left 10mm catalog #: 42511200510 lot #: 63603266, persona stemmed cemented tibial component left size f catalog #: 42532007501 lot #: 63749526, persona cemented all poly patella catalog #: 42540000035 lot #: 63873119.The product has been received by zimmer biomet and 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.H6 - component code - proposed code is mechanical femur (g04).Visual evaluation of returned devices found that the femur's blasted surface exhibited staining and the color-buffed surface exhibited minor scratches and staining with nicks and dings along the edge.The articular surface was not returned.Radiographic review identified extensive radiolucency reflecting osteolysis around the femoral implant, which appeared to be loose.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.

• Brand Name: PERSONA CEMENTED CRUCIATE RETAINING STANDARD FEMORAL COMPONENT LEFT SIZE 10
• 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: 19802139
• Report Number: 3007963827-2024-00285
• Device Sequence Number: 18218440
• Product Code: JWH
• UDI-Device Identifier: 00889024230415
• UDI-Public: (01)00889024230415(17)271031(10)63840803
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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: 42502606801
• Device Lot Number: 63840803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male