MAUDE Adverse Event Report: ZIMMER BIOMET, INC.; PROSTHETIC, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Failure of Implant (1924); Pain (1994); Respiratory Distress Syndrome of Newborns (2046); Synovitis (2094); Metal Related Pathology (4530)

Event Date 11/18/2019

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure 11 years post implantation due to increasing pain and elevated cobalt and chromium levels.Trunnion corrosion and synovitis were noted.During this revision, the head and liner were replaced, and all other components including the stem remained intact.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).D1: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 10 standard offset d10: 00801803214 item name femoral head nonskirted 12/14 taper lot # 60823995.6305-50-32 item name trilogy acetabular system longevity liner lot # 60878048.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01378 the device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device remains implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 mechanical g04 - stem.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed, with a revision occurring a year and a half later.A second revision occurred 11 years after that due to pain and elevated metal ions.During the revision trunnion corrosion and discoloration was noted, as well as synovitis within the joint.The head and liner were explanted and replaced with no complications noted.Root cause unchanged.This complaint was confirmed based on the provided medical records.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

There is no update to the prior event description provided.

• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17904158
• MDR Text Key: 325274202
• Report Number: 0001822565-2023-02772
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

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: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 00771101000
• Device Lot Number: 60509888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female