MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 : unknown - unknown palacos cement - unknown.42512100712 - articular surface medial congruent (mc) left 12 mm height use with tibia sizes e-f/cr femur sizes 6-7 - 63846099.Unknown - unknown tibial component - unknown.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
It was reported that the patient underwent an initial knee surgery.Approximately 4 years postop, the patient reported pain and was revised due to femoral loosening.The surgeon was able to pull the cemented femur off without using any instruments.The cement adhered to the patient's bone but not to the implant.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6 : suggested component code- mechanical (04)- femur.Visual examination of the returned product found the femoral to exhibit signs of being implanted scratched / stains.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.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 FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD
• 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: 18967843
• Report Number: 3007963827-2024-00077
• Device Sequence Number: 6279639
• Product Code: MBH
• UDI-Device Identifier: 00889024230354
• UDI-Public: (01)00889024230354(17)290331(10)64255995
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 07/17/2024

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: 42502606201
• Device Lot Number: 64255995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male