MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CRUCIATE RETAINING CEMENTED NARROW FEMORAL COMPONENT RIGHT SIZE 6; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Cellulitis (1768); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 04/23/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a right knee arthroplasty revision to address severe pain, swelling, instability, difficulty performing daily activities and difficulty straightening the right leg approximately four (4) months post-operatively, despite home exercises and therapy.Initial operative notes noted no intraoperative complications, however, the patient was additionally treated intravenously five (5) days post-operatively for cellulitis.Revision operative notes noted the patient had obvious valgus alignment of the tibial component, however, all components were found to be well-fixed and no wear or damage was seen with the patella.The patient's range of motion at the end of the procedure was 0-125 degrees.Attempts have been made, however, no additional information is available.

Manufacturer Narrative

(b)(4).D10 - concomitant devices - persona cemented stemmed tibial component right size d catalog #: 42532006702 lot #: 64374539, persona ultracongruent articular surface right 13mm catalog #: 42522200413 lot #: 63551523, persona cemented all-poly patella 32mm catalog #: 42540200032 lot #: 64516140, persona stem extension tapered cemented 14 mm diameter +30 mm length catalog #: 42557000114 lot #: 64529728.The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2023-00162, 0001822565-2020-00460, 0002648920-2023-00121 and 0001822565-2023-01623.This report was previously submitted erroneously on feb 6, 2020 and jun 10, 2020 under manufacturing report number 0001822565-2020-00459.H3 other text : investigation incomplete.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 - component code - proposed code is mechanical (g4) femur.Medical records provided and previously reported confirm the reported event.The device history records were reviewed and no discrepancies were identified.The reported infection was found to not be related to the device, however, a definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: PERSONA CRUCIATE RETAINING CEMENTED NARROW FEMORAL COMPONENT 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: 17133975
• MDR Text Key: 317214777
• Report Number: 3007963827-2023-00161
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024229907
• UDI-Public: (01)00889024229907(17)290731(10)64468330
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

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: 42502006002
• Device Lot Number: 64468330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2019
• 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): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 62 KG