MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE PROVISIONAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product location unknown.

Event Description

It was reported that the provisional had fractured during trialing process.All pieces were retrieved from the surgical site.No more information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned articulate surface provisional confirms that the device was fractured and all pieces were returned for evaluation.It also shows signs of repeated use (nicks and gouges).Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required the root cause of the reported event can be attributed to the wear and tear from use.There are warnings in the package insert that this type of event can occur and risks are addressed in the associated risk documentation.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.

• Brand Name: NEXGEN ARTICULAR SURFACE PROVISIONAL
• 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: 7026394
• MDR Text Key: 91893638
• Report Number: 0001822565-2017-07834
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00596104110
• Device Lot Number: 61635645
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 02/12/2018; 03/12/2018
• Supplement Dates FDA Received: 02/13/2018; 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2010
• 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): Other