MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PPK TIBIAL CUTTING BLOCK; INSTRUMENT, KNEE

Model Number N/A

Device Problems Fracture (1260); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 08/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign (b)(6).It is unknown if product will be returning to zimmer biomet and 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.

Event Description

It was reported that during a right total knee arthroplasty, when fixing the tibial cutting block, two pins got stuck in the vertical slot.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this product did not cause or contribute to the event.

Event Description

Upon receipt of additional information, it has been determined that this product did not cause or contribute to the event.

• Brand Name: PPK TIBIAL CUTTING BLOCK
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7645618
• MDR Text Key: 112749645
• Report Number: 0001825034-2018-04289
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42-5399-052-85
• Other Device ID Number: N/A
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 11/16/2018
• Supplement Dates FDA Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 52