MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR RED/LAT 15X150; PROSETHESIS, HIP

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem Osteolysis (2377)

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 157454 ¿ m2a magnum head ¿ 043880, 139268 ¿ m2a magnum taper - 536830, us157860 ¿ m2a magnum cup ¿ 773080.Complaint sample was evaluated and the reported event was confirmed.Upon receipt, the head, taper and stem were stuck together.Visual inspection identified damaged to the taper, likely due to the hard strikes caused by the surgeon attempting to remove the stem.Visual inspection of the outer surface of the head identified scuffs and scratches.There was bio debris on the stem and the porous coating on the stem is peeling off.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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 - 2018 - 10696.

Event Description

It was reported patient underwent a revision surgery due to osteolysis at an unknown amount of time post implantation.During the procedure, the head and adapter could not be removed from the stem component.The stem and head components were removed and replaced resulting in about 45 min of a delay in the surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TAPERLOC POR RED/LAT 15X150
• Type of Device: PROSETHESIS, HIP
• 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: 8842414
• MDR Text Key: 152678690
• Report Number: 0001825034-2019-03311
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030055
• 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
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 13-103208
• Device Lot Number: 804050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2008
• 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): Hospitalization; Required Intervention