MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERRSONA PARTIAL KNEE TIBIAL TRAY; PROSTHESIS KNEE

Model Number N/A

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

Patient Problem Bone Fracture(s) (1870)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 42558000401, partial femur cemented size 4 left medial, lot # unk catalog #: 42518200808, partial articular surface left medial size h, lot # unk.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

It was reported that the patient had a tibial fracture after a persona partial knee procedure approximately 4 months ago.

Manufacturer Narrative

(b)(4).The information provided on this form was previously submitted under manufacturing report number 0001825034-2018-02256.

Event Description

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

• Brand Name: PERRSONA PARTIAL KNEE TIBIAL TRAY
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7592723
• MDR Text Key: 110789969
• Report Number: 0001825034-2018-03907
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: PK161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42538000801
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 134