MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR CEMENTED CRUCIATE RETAINING (CR); PROSTHESIS KNEE

Model Number N/A

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

Patient Problem Metal Related Pathology (4530)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: tibia stemmed catalog #: 42532007102, lot #: 65690974.Articular surface medial congruent (mc) catalog # 42522100810 lot # 65634264.All-poly patella catalog # 42540200035 lot # 65777311.Headless trocar drill pin catalog # 00590102000 lot # 65701807.2.5 mm female hex screw catalog # 42509902525 lot # 65726727.H3: customer has indicated that the product will not be returned because requested but not returned by hospital.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a revision procedure ten months post implantation due to metal allergy.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

No further event information available at the time of this report.

• Brand Name: PERSONA FEMUR CEMENTED CRUCIATE RETAINING (CR)
• 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: 19062625
• MDR Text Key: 339667384
• Report Number: 3007963827-2024-00106
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024229945
• UDI-Public: (01)00889024229945(17)330105(10)65594459
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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: 42502006402
• Device Lot Number: 65594459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2023
• 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): Hospitalization; Required Intervention
• Patient Sex: Female