MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE LEFT 14MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: concomitant devices - persona cemented stemmed tibial component left size f catalog#: 42532007501, lot#: 65284975, 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: 3007963827-2024-00068, 0001822565-2024-00856.H3 other text: investigation incomplete.

Event 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 ultracongruent articular surface was used to correct the articulation.The patient was satisfied following the procedure.

• Brand Name: PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE LEFT 14MM
• Type of Device: 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: 18882009
• MDR Text Key: 337408384
• Report Number: 3007963827-2024-00067
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024469259
• UDI-Public: (01)00889024469259(17)251120(10)64842823
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42512100714
• Device Lot Number: 64842823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male