MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Ossification (1428); Pain (1994)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:00801803202 lot number:62516821 brand name: cocr heads, catalog number:00620005422 lot number:62517074 brand name: trilogy cup, catalog number:00630505032 lot number:62501592 brand name: acetabular liner, catalog number:00625006535 lot number:62417712 brand name: bone screw.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2018-00426, 0002648920-2019-00744.Medical records were provided and reviewed by a health care professional.Review of the available records identified that the patient developed increasing pain and underwent a revision procedure.Lab tests showed that the patient had elevated metal ions: cobalt at 3.4 and chromium at 1.1.During the procedure, significant corrosion was observed at the head-taper interface.Ectopic bone was excised from around the acetabulum.No other findings related to the reported event were noted.Reported event was confirmed by review of medical records provided.Device history record 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.

Event Description

It was reported that the patient was revised due to increasing pain approximately 3 years post implantation.During the surgery surgeon notes significant corrosion to head/neck junction, elevated metal ions, and ectopic bone growth at the acetabular component.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA
• 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: 9198164
• MDR Text Key: 162629804
• Report Number: 0001822565-2019-04419
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161830
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00771101110
• Device Lot Number: 62540656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention