MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET FIXED I-BEAM TIBIAL PLATE INTERLOK - WITH LOCKING BAR; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) concomitant medical product - van ps open intl fem-rt 72.5 catalog # 183113 lot# j3815863u, series a pat thn 34 3 peg catalog# 184786 lot# 602490, vngd ps tib brg 10x71/75 mm catalog# 183640 lot# 926880 reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that patient underwent a revision due to dissociation of the locking bar one month post implantation.The locking bar was replaced and all other components remain implanted.

• Brand Name: BIOMET FIXED I-BEAM TIBIAL PLATE INTERLOK - WITH LOCKING BAR
• 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: 7422803
• MDR Text Key: 105202650
• Report Number: 0001825034-2018-02533
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 141224
• Device Lot Number: J6131396
• Other Device ID Number: 01) 0 0880304 00751 2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR