MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 30MM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Bacterial Infection (1735)

Event Date 12/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 650-1064 ¿ ceramic taper ¿ 3064989.650-1055 ¿ ceramic head ¿ 2020011173.47249009700 ¿ tear drop guide wire ¿ 65316177.166069 ¿ arcos screw ¿ 6828663.166069 ¿ arcos screw ¿ 7032015.166070 ¿ arcos screw ¿ 6970413.166068 ¿ arcos screw ¿ 7053131.166067 ¿ arcos screw ¿ 7197916.Report source: report source australia.Product will not be returned to zimmer biomet for the investigation as the product was discarded.The investigation is in process.Once the investigation as been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00091, 0001825034 - 2023 - 00092, 0001825034 - 2023 - 00093, 0001825034 - 2023 - 00094, 0001825034 - 2023 - 00095, 0001825034 - 2023 - 00097, 0001825034 - 2023 - 00098.

Event Description

It was reported that patient underwent a first stage revision of the left total hip arthroplasty approximately 1 month post implantation due to a bacterial infection.All components were removed.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A radiograph was provided and reviewed by a health care professional.As the complaint is infection related the x-ray did not enhance the investigation.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.No device problem was found.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, implanted products are not identified as the source or contributing to the reported 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.

• Brand Name: G7 SCREW 6.5MM X 30MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16195447
• MDR Text Key: 307597735
• Report Number: 0001825034-2023-00096
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527478
• UDI-Public: (01)00880304527478(17)320708(10)7289383
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000999
• Device Lot Number: 7289383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2022
• 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.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 185 KG