MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER PERSONA - NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING L PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Migration (4003)

Patient Problem No Information (3190)

Event Date 12/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: palacos rg 1x40 single, catalog #: 00111314001, lot #: 75774319, qty: 2; articular surface fixed bearing posterior stabilized (ps) left 12 mm height, catalog #: 42512400712, lot #: 62197498; femur cemented posterior stabilized (ps) standard left size 8, catalog #: 42500606401, lot #: 62127369; all-poly patella cemented 32 mm diameter, catalog #: 42540200032, lot #: 62235042. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product location unknown.

Event Description

It was reported the patient underwent a left total knee arthroplasty. Subsequently, the patient underwent a revision due to loosening of the tibial tray approximately fours years post-implantation. Operative reports further noted that during the revision procedure the patient was also noted to have fibrosis of the left total knee arthroplasty. Furthermore, the patient was noted to have instability prior to the revision procedure which required a brace.

• Brand Name: ZIMMER PERSONA - NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING L
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7741599
• MDR Text Key: 115763974
• Report Number: 0001822565-2018-03587
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,OTHER

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/01/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: N/A
• Device Catalogue Number: 42530007501
• Device LOT Number: 62268137
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 03/18/2013
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient TREATMENT DATA

Date Received: 08/01/2018 Patient Sequence Number: 1