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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Report source: foreign: singapore.Complaint could not be confirmed.Examination of the returned sizing plate exhibits signs of repeated use (nicked or gouged) and the returned locking handle held the sizing plate firmly when performing functional check.Functional check was also performed on locking handle using gages and results were noted as go passed and the no go did not.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.Returned products were determined to be conforming and function properly.No failure detected.Root cause was unable to be determined.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: 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
• 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
• PMA/PMN Number: EXEMPT
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 64 YR