MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ART SURFACE MC LEFT 14MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Synovitis (2094)

Event Date 08/11/2020

Event Type  Injury  

Event Description

It was reported a patient had an initial left total knee arthroplasty followed by a i&d with poly exchange about one month post implantation for infection.Subsequently, the patient began to experience persistent pain and swelling and upon assessment was diagnosed with mechanical loosening.Two years, five months after the i&d revision the patient underwent a revision due to aseptic failure.During the revision, encountered synovitis, pitting to the poly from third body wear, and defects noted on the femoral and tibial components.All components were revised without complication.

Manufacturer Narrative

(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products.(b)(6) persona natural tibia cemented 5 deg stemmed left sz g lot# 63717624.(b)(6) persona femoral cemented cr std left sz 9 lot# 63681226.(b)(6) persona all poly patella cemented 41mm dia 10mm lot# 63716234.(b)(6) palacos r 1x40 single lot# 86934602.(b)(6) palacos r 1x40 single lot# 86934602.

• Brand Name: PERSONA ART SURFACE MC 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: 19159425
• MDR Text Key: 340798047
• Report Number: 3007963827-2024-00135
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024469419
• UDI-Public: (01)00889024469419(17)221031(10)63841871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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 Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42512100914
• Device Lot Number: 63841871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2017
• 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): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White