MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CEMENTED STEMMED TIBIAL COMPONENT LEFT SIZE F; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Mechanical Jam (2983); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10 - concomitant devices - persona medial congruent articular surface left 14mm catalog #: 42512100714 lot #: 64842823, persona tm cruciate retaining standard porous femoral component left size 7 catalog #: 42502806201 lot #: 65313458, persona all-polyethylene cemented patella 32mm catalog #: 42540200032 lot #: 65710733 g2 - report source - foreign: event occurred in australia the complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2024-00067, 0001822565-2024-00856, h3 other text : investigation incomplete.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision of the articular surface to address pain, swelling and limited range of motion approximately one (1) year post-operatively.Reportedly, the rotation of the tibia had resulted in conflict during flexion and the femoral component was not interacting with the articular surface correctly.An ultra congruent articular surface was used to correct the articulation.The patient was satisfied following the procedure.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision of the articular surface to address pain, swelling and instability that was interfering with range of motion approximately one year post-operatively.The surgeon reported that the tibial rotation did not match the correct placement for a medial congruent bearing as the soft tissues were too tight to allow component articulation.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records provided.Device was not returned.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 tibial rotation did not align for correct placement of bearing during articulation causing kinematic conflict; knee effusion; patient presented with ongoing pain, swelling and clicking with instability; impingement of soft tissues; change of bearing rectified the issue.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 CEMENTED STEMMED TIBIAL COMPONENT LEFT SIZE F
• 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: 18882008
• Report Number: 3007963827-2024-00068
• Device Sequence Number: 15766872
• Product Code: JWH
• UDI-Device Identifier: 00889024471078
• UDI-Public: (01)00889024471078(17)320207(10)65284975
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 06/21/2024

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: 42532007501
• Device Lot Number: 65284975
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: 05/09/2024; 06/18/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 05/29/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 83 KG