MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPRESS SEGMENTAL ANCHOR PLUG; PROSTHESIS, KNEE

Model Number N/A

Device Problems Component Incompatible (1108); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been returned for investigation.The investigation is in process.Once the investigation is completed, a supplemental will be filed.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 during a knee arthroplasty, the anchor plug implant was too short and would not screw into the pin alignment guide.As a result, there was a thirty minute delay.

Manufacturer Narrative

It was determined this device did not cause or contribute to a serious injury and has been determined to be a non reportable malfunction.Please void this submission.

Event Description

It was determined this device did not cause or contribute to a serious injury and has been determined to be a non reportable malfunction.Please void this submission.

• Brand Name: COMPRESS SEGMENTAL ANCHOR PLUG
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8259151
• MDR Text Key: 133459699
• Report Number: 0001825034-2019-00239
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K043547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

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 Expiration Date: 10/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 178408
• Device Lot Number: 031490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/17/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention