MAUDE Adverse Event Report: BIOMET UK LTD. TIBIAL RESEC HEAD-LEFT W/ALIG; KNEE PROSTHESIS

Model Number N/A

Device Problems Defective Device (2588); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that the left vanguard tibial cut block would not thread onto tibial resection guide.It was determined that it was the cut block that was the issue as the right block threaded on just fine.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, h1, h2, h3, h6.It was reported that the left vanguard tibial cut block would not thread onto tibial resection guide.It was determined that it was the cut block that was the issue as the right block threaded on just fine.Visual inspection confirmed the reported event.The component will not assembly with its matting instrument by using the thread which is damaged.Metal pick up is observed on the damaged 3rd and 4th threads.The root cause of the reported event could not be determined with the information provided in the complaint.The mating instrument has not been returned with the damaged component to confirm whether it is what damaged the reported event.Device history record (dhr) was reviewed and no discrepancies were found.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

Instrument would not assemble onto mating instrument.

• Brand Name: TIBIAL RESEC HEAD-LEFT W/ALIG
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8944149
• MDR Text Key: 156722911
• Report Number: 3002806535-2019-00710
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 00880304434752
• UDI-Public: 00880304434752
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• 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: 32-487556
• Device Lot Number: ZB151102
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/16/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1