MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR LAT FMRL 15X150; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Pain (1994); Local Reaction (2035); Osteolysis (2377)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet m2a magnum tpr adpr ti dia52-6 0/0mmt1 cat#139268 lot#201540.Biomet m2a-magnum pf cup 62odx56id cat# us157862 lot# 305750.Biomet m2a-magnum mod hd sz 56mm cat# 157456 lot# 297070.Complaint was confirmed by op notes which indicated patient was revised due to metallosis.Upon opening, thick fibrotic avascular tissue consistent with an acute local tissue reaction was noted.The density of the fibrotic scar tissue had eroded the proximal femur and resulted in impingement anteriorly.Review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.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: 0001825034-2017-02396, 0001825034-2017-02395, 0001825034-2020-02230.

Event Description

It was reported that patient was revised approximately 5 years post-implantation due to pain, metallosis, impingement, altr, and elevated metal ion levels.No further event information available at the time of this report.

• Brand Name: TAPERLOC POR LAT FMRL 15X150
• 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: 10114946
• MDR Text Key: 193673866
• Report Number: 0001825034-2020-02228
• Device Sequence Number: 1
• Product Code: LZO
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 11-103208
• Device Lot Number: 637400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• 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): Other