MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BIOMET 360 TIBIAL AUGMENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: (b)(4).Associated product bmt 360 tib aug 63x5mm item# 185221 lot# 904740, bmt 360 tib aug 67x5mm item# 185222 lot# 947570.(b)(6).The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that, during a knee procedure, a screw didn't mate with the tibial augment.Subsequently, a screw for an alternative augment was used to complete the procedure.There is no additional information at this time.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.Corrected: d1, d4, and g4 visual inspection of the returned screw components found both to exhibit some cosmetic damage one of the screw threads were found to be damaged and the second screw threads were conforming.However, it is not confirmed which screw was the one used with reported part.Medical records were not provided.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause cannot be confirmed.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: UNKNOWN BIOMET 360 TIBIAL AUGMENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11220204
• MDR Text Key: 234300209
• Report Number: 0001825034-2021-00162
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00880304481572
• UDI-Public: (01)00880304481572
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 185221
• Device Lot Number: 904740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/23/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1