MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Synovitis (2094); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 02/14/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown-unknown stem size 10 mlt-unknown.00630505840- liner standard 3.5 mm offset 40 mm i.D.For use with 58 mm o.D.Shell-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00700.Visual examination of the provided pictures identified slight discoloration on the trunnion of the implanted stem and inside the head.All products were covered in bio-debris, and no further evaluation can be made from the provided pictures.Part and lot identification are necessary for review of device history records; lot identification was not provided for the head.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.Not returned by attorney.

Event Description

It was reported patient underwent left hip revision approximately 11 years post implantation due to metallosis.During the procedure the head and acetabular liner were removed.Liner was damaged upon removal.There were some signs of discoloration inside the femoral head and on the trunnion of the stem.A new liner and a biolox option head were re implanted.Pt cobalt level was noted as 5.1.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).This event will be reported under this mfr number: 0002648920 - 2023 - 00161.

Event Description

No further information at the time of this report.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• 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: 13712871
• MDR Text Key: 287009390
• Report Number: 0001822565-2022-00698
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• 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: 07/07/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00801804001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 35 KG