MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 11 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 04/08/2024

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial surgery.Approximately one year later, the patient was revised due to loosening, pain, and instability.During the surgery, the surgeon also noted that the femoral component was internally rotated and oversized.Only the tibial component and poly were revised.Attempts have been made and all available information has been provided.

Manufacturer Narrative

(b)(4).D10: 42530007102 - tibia trabecular metal two-peg porous fixed bearing right size e - 65262049.42502206602 - femur trabecular metal cruciate retaining (cr) narrow porous - 64894341.42540200032 - all-poly patella cemented 32 mm diameter - 65594007.G2 : foreign country : australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 11 MM HEIGHT
• 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: 19172686
• MDR Text Key: 340921892
• Report Number: 3007963827-2024-00143
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024468429
• UDI-Public: (01)00889024468429(17)270125(10)65281194
• 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: 04/23/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42522100811
• Device Lot Number: 65281194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female