MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TITANIUM SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 10/29/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-173662 ¿ m2a head ¿ 989820, 15-105058 ¿ m2a shell ¿ 939650, 11-104212 ¿ mallory head stem ¿ 998540, 113847 ¿ titanium screw - 057770.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the head component found black debris inside the taper.A small ding was observed on the flat neck-side of the head.The outer radius exhibits scuffing and wear consistent with a metal on metal hip construct.Visual inspection of the cup found the inner radius to be scuffed and worn consistent with a metal on metal construct.Debris was found on the rim of the shell.Bone cement also remains affixed to the outer radium and the front right pin is chipped.Two screws were returned.One is lightly worn with minor dings.The other is fractured.The threads of the screw are nearly encapsulated in bone cement.The portion of the threads that are visible are not complete and have been ground/sheared off.Sem analysis of the head showed evidence of dark and light colored deposits on the taper surface.Sem/eds analysis was conducted subject to certain constraints.X-ray detection in the sem is limited to a line-of-sight from the sample to the fixed eds detector.There are geometric constraints on the area of a bore sample that can be analyzed without sectioning of the sample.The modular head was mounted in the sem such that the taper axis made a shallow angle to the horizontal plane and the taper opening was pointed towards the eds detector.This permitted sem/eds analysis of only a narrow region close to the taper opening.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2015-01217, 0001825034-2015-01218, 0001825034-2020-02232.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 patient underwent a left hip revision approximately 7 years post implantation due to pain, stiffness, trouble walker, difficulty sleeping, atrophy of left hip flexor muscle, limp, metal debris, and elevated metal ions.During the surgery, mild fretting and corrosion on the head and taper was noted and the head and cup components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TITANIUM SCREW
• 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: 10120571
• MDR Text Key: 195518332
• Report Number: 0001825034-2020-02233
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030710
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 113848
• Device Lot Number: 469130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• 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?: Yes
• Date Device Manufactured: 06/05/2006
• 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