MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA¿ VIVACIT-E®; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Date 08/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: femur cemented posterior stabilized (ps) standard left size 7 catalog 42500606201 lot 64186094; natural tibia cemented 5 degree stemmed left size e catalog 42532007101 lot 64293425; all poly patella cemented 32 mm diameter catalog 42540000032 lot 64197081, 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 post knee arthroplasty the patient experienced procedure related complication of electrolyte imbalance of low sodium level, which required medical intervention and increased the patient¿s hospital length of stay.

Event Description

No additional information reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h1, h2, h3, h6, h10.Hyponatremia is a decrease in serum sodium concentration caused by an excess of water relative to solute; in this case the patient was one day post-operative and it is unknown what medications the patient was using or the amount of fluid the patient received intra-operatively, which may contribute to hyponatremia.This condition is unrelated to device and likely related to patient comorbidities or related to procedure in which the patient received medications and iv fluids.This event is no longer considered a reportable event as the device did not cause/ contribute to the event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA¿ VIVACIT-E®
• 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: 9012042
• MDR Text Key: 160440481
• Report Number: 3007963827-2019-00262
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

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 Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 42512400711
• Device Lot Number: 64281984
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 92