MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM CONSTR HD 36MM T1 -6MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Fracture (1260); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Ossification (1428); Failure of Implant (1924); Inflammation (1932); Pain (1994); Joint Dislocation (2374); Metal Related Pathology (4530)

Event Date 11/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Cat# 105423 rnglc locking ring sz 23 lot#467890.Cat# 103202 taperloc por fmrl 7.5x135 lot#521400.Cat#103533 ti low profile screw 6.5x30mm lot#374270.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 - 01615 and 0001825034 -2021-03329.

Event Description

It was reported that the patient underwent a left hip arthroplasty.Subsequently, patient was revised due to dislocation approximately 1.5 months later.The patient was revised again approximately 2 months later due to dislocation and it was found that the liner had fractured.Subsequently, approximately 4 years later, the patient was revised again due to pain, recurrent dislocation, and noise.During the revision, it was found that the cup had broken at the base due to mechanical impingement with flexion.The ring and liner were also fractured resulting in metallosis and pseudotumor formation.All components were replaced without complication.No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; h2; h3; h4; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: dislocations, pain, fracture, heterotopic ossification, liner wear, squeak, metallosis, and tumor.A review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause cannot 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.

• Brand Name: FREEDOM CONSTR HD 36MM T1 -6MM
• 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: 12969541
• MDR Text Key: 284986323
• Report Number: 0001825034-2021-03328
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-107016
• Device Lot Number: 794290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2015
• 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
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American