MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NSTRIDE APS KIT WITH ACD-A; HAEMATOLOGICAL CONCENTRATE SYSTEM

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Staphylococcus Aureus (2058)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4), the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Patient received an injection in their right knee.The patient was hospitalized approximately 7 days later for an infection of the right knee and treated with antibiotics and synovectomy of the knee.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.No product was returned; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies were found.Review of sterilization certification confirms devices were sterilized in accordance with iso 11137-2.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

No additional information received.

• Brand Name: NSTRIDE APS KIT WITH ACD-A
• Type of Device: HAEMATOLOGICAL CONCENTRATE SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8338859
• MDR Text Key: 136124436
• Report Number: 0001825034-2019-00609
• Device Sequence Number: 1
• Product Code: PZT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 800-3000ST
• Device Lot Number: 702061
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 70