MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR FMRL 10X140; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem No Code Available (3191)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: m2a-magnum pf cup 52odx46id pn us157852, lot 090950, m2a-magnum 46-50 t, pn cp162166, ln 625460.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019-02143.Complaint sample was evaluated and the reported event was confirmed.Reported event was confirmed by review of visual examination of the provided pictures identified the taper is assembled to the head.The taper has damages and scratches likely caused during removal.The inside taper of the head identified dark debris consistent with corrosion.No other evaluation can be made.Device history record (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.Zimmerbiomet will continue to monitor for trends.

Event Description

It was reported that patient underwent a revision procedure approximately 8 years post-implantation due to elevated metal ion levels.Attempts were made to obtain additional information; however, none was available.

• Brand Name: TAPERLOC POR FMRL 10X140
• Type of Device: PROSTHESIS, 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: 9078480
• MDR Text Key: 158873258
• Report Number: 0001825034-2019-04148
• Device Sequence Number: 1
• Product Code: KWY
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 103204
• Device Lot Number: 608450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2010
• 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