MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE G; PROSTHESIS, KNEE

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577)

Event Date 07/11/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2024-00063, 3007963827-2024-00064, and 3007963827-2024-00065.D10 medical devices: persona femur cemented (cr) standard left size 11 catalog#: 42502607001 lot#: 65352041 persona art.Surface fixed bearing (uc) left 11 mm height catalog#: 42512200611 lot#: 64416943.Persona all poly patella cemented 41 mm diameter catalog#: 42540000041 lot#: 65223568.Biomet bc r 1x40 us catalog#: 110035368 lot#: az44ak0204.Biomet bc r 1x40 us catalog#: 110035368 lot#: az44ak0204.Biomet bc r 1x40 us catalog#: 110035368 lot#: az44ak0204.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Legal allegations reported that patient underwent a right knee revision.Subsequently, the patient began to experience pain, joint effusions, impingement, swelling, stiffness, arthrofibrosis with limited range of motion, and mid-flexion instability.Radiographic imaging displayed osteolysis at the cement bone interface of the femoral component anteriorly and posteriorly, and progressive radiolucency under the anterior flange and the posterior cut of the femoral component.Approximately eleven months post-implantation, the patient was revised due to aseptic loosening of the femoral component.Substantial scar tissue was noted during the revision.The tibial component was revised due to being slightly undersized and medialized.All components, except the patella, were exchanged for competitor product and the surgery was completed without complication.

• Brand Name: PERSONA TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE G
• 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: 18890605
• MDR Text Key: 337510835
• Report Number: 3007963827-2024-00065
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024471092
• UDI-Public: (01)00889024471092(17)320426(10)65349341
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532007901
• Device Lot Number: 65349341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 113 KG