MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE ARTICULAR SURFACE LEFT MEDIAL SIZE D 8MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a hair-like substance was found in the sterile packaging of the articular surface implant when it was opened during knee arthroplasty.Another articular surface was used to complete the procedure.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint sample was evaluated, however, visual inspection of the product and packaging found no evidence of foreign debris.The device history records were reviewed and no discrepancies were identified.As there was no evidence to support the presence of foreign debris in the sterile packaging, 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 PARTIAL KNEE ARTICULAR SURFACE LEFT MEDIAL SIZE D 8MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10516734
• MDR Text Key: 206523044
• Report Number: 0001825034-2020-03467
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42518200408
• Device Lot Number: 64502908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1