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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fibrosis (3167)

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 42522200510 - articular surface fixed bearing ultracongruent (uc) right 10 mm height - 65548630.42540200029 - all-poly patella cemented 29 mm diameter - 65722110.42502606602 - femur cemented cruciate retaining (cr) standard right size 9 - 65432541 66022663 - palacos r + g (1x40) - 62691185.G2 : foreign country : australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2024-00089.

Event Description

It was reported that the patient underwent an initial knee surgery and approximately 11 months later, the patient was revised due to arthrofibrosis.The tibial component and poly were revised.Attempts have been made and all available information has been provided.

• Brand Name: PERSONA TIBIA CEMENTED 5 DEGREE STEMMED RIGHT
• 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: 19003342
• MDR Text Key: 338898389
• Report Number: 3007963827-2024-00088
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024471085
• UDI-Public: (01)00889024471085(17)320924(10)65482034
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172524
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532007502
• Device Lot Number: 65482034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male