MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS); PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: persona femur cemented posterior stabilized (ps), catalog # 42500605802, lot # 63982839; persona stemmed tibia, catalog # 42532006702, lot # 64078277; persona all poly patella, catalog # 42540000029, lot # 64214476.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2019-00069, 3007963827-2019-00070, 0002648920-2019-00193.Remains implanted.

Event Description

It was reported that the patient underwent a right knee arthroplasty.Subsequently, the patient was experiencing deep vein thrombosis one month post operative.No revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of medical records.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of available medical records indicates there is no complication during the primary surgery and patient experienced dvt after surgery.Per the health care professional, dvt is a procedure-related event and is not implant related.Therefore, no failure detected related to the implant.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.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS)
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 8418000
• MDR Text Key: 138708373
• Report Number: 3007963827-2019-00071
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42522400410
• Device Lot Number: 64207001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 59