MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET 360 TIBIAL CRUCIATE WING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Failure to Align (2522)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: biomet 360 tibial tray, cat#: 185204 lot#: 458430, vanguard tibial bearing, cat#: ep-189086 lot#: 665840, biomet splined knee stem, cat#: 148291 lot#: 778020.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-08625, 0001825034-2017-08626.

Event Description

It was reported that the trial was misaligned from the implant.The cement had hardened before the implant could be disassembled and removed.The surgery was delayed by twenty minutes for additional implants to be delivered to complete the case.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-08625, 0001825034-2017-08626, 0001825034-2017-11272, 0001825034-2017-11274 complaint sample was evaluated and the reported event was not confirmed.A bearing, locking bar, screw, and tibial tray assembled with stem and cruciate wing were returned and evaluated.The trial tibial tray and trial cruciate wing were not returned.The tray, cruciate wing, and stem assembly was returned with foreign material.Dimensional analysis could not be completed due to the foreign material.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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.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: BIOMET 360 TIBIAL CRUCIATE WING
• 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: 6945437
• MDR Text Key: 90309173
• Report Number: 0001825034-2017-08625
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK140883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• 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: 185650
• Device Lot Number: 473480
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2017
• 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): Required Intervention