MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR CEMENTED (PS) STANDARD RIGHT SIZE 6; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Inflammation (1932); Swelling/ Edema (4577)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 medical devices: persona art.Surf.Fixed bearing (ps) right 11 mm height, catalog#: 42522400711, lot#: 64013879.Persona tibia cemented 5 degree stemmed right size e, catalog#: 42532007102, lot#: 63969048.Persona stem extension tapered cemented 14 mm diameter +30 mm, catalog#: 42557000114, lot#: 64069281.G2 foreign source: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a right knee arthroplasty.Subsequently, approximately six years later, the patient reports swelling and inflammation around the knee.No intervention has been reported.

• Brand Name: PERSONA FEMUR CEMENTED (PS) STANDARD RIGHT SIZE 6
• 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: 19124145
• MDR Text Key: 340355583
• Report Number: 3007963827-2024-00120
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024229204
• UDI-Public: (01)00889024229204(17)280430(10)63945121
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113369
• 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: 04/17/2024

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: 42500606002
• Device Lot Number: 63945121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2018
• 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
• Patient Outcome(s): Other