MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN SIZING PLATE FOR STEMMED TIBIAL SIZE 5 INSTRUMENT

Model Number N/A

Device Problems Positioning Failure (1158); Loose or Intermittent Connection (1371)

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

Event Date 06/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Customer 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. Concomitant medical products: locking tibial tray provisional handle, item # 00597709600, lot # 60714066. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02818.

Event Description

It was reported that during an initial surgery that the tibial plate, locks on too loosely and insecurely to the provisional handle. Attempts have been made, and no further information has been provided.

• Brand Name: NEXGEN SIZING PLATE FOR STEMMED TIBIAL SIZE 5
• Type of Device: INSTRUMENT
• 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: 8760458
• MDR Text Key: 150014210
• Report Number: 0001822565-2019-02817
• Device Sequence Number: 1
• Product Code: LHX
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 00597701205
• Device Lot Number: 60074761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Removal/Correction Number: N/A