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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scar Tissue (2060); Sepsis (2067); Osteopenia/ Osteoporosis (2651)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 110010265 ¿ g7 multihole cup - 3863830.110017220 - g7 liner ¿ 3579795.010000997 ¿ g7 screw ¿ 3865243.010000997 ¿ g7 screw ¿ 3847793.010000997 ¿ g7 screw ¿ 3874188.010000997 ¿ g7 screw ¿ 3855555.010000999 ¿ g7 screw ¿ 3871319.010001001 ¿ g7 screw ¿ 3855562.00877703603 ¿ biolox delta head ¿ 2790040.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a right hip revision due to pain and metal related pathology approximately 7 years post implantation.Subsequently, the patient visited the er due to dislocations, pain and swelling with no noted medical intervention.The patient then underwent a second revision approximately 4 years later due to chronic infection.All devices were removed and replaced with spacers.Approximately 1 month later the patient still had ongoing infection despite use of antibiotics, so new spacers were implanted along with wires.There is no report or new permanent implants being implanted to date.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.The reported event of deep infection occurred greater than 90 days¿ post implantation.It is noted that the femoral implant was placed during initial procedure and a revision surgery of other hip components was performed and they retained the femoral component.The femoral component was not explanted/revised till the patients second, first stage revision when infection was identified and spacers placed.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.Patient is noted to have elevated bmi of 49.6, morbid obesity, this increases the risk for developing infections.It should be noted the first revision surgery of all components except for femoral component, increases the risk for developing an infection.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

No additional information on the reported event.

• Brand Name: FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK 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: 12432355
• MDR Text Key: 270064943
• Report Number: 0001822565-2021-02475
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00786401220
• Device Lot Number: 61209287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2009
• 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: Male
• Patient Weight: 127 KG