MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 25MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)

Event Date 05/30/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01382.D10: cat# 010000935; lot# 7252639; g7 hi-wall; e1 liner 36mm; e unknown competitor head.G2: foreign: australia ; the customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a right hip procedure that was subsequently revised approximately 12 days later due to an acetabular fracture.It was noted in x-rays that the acetabular component had loosened, and osteopenia was present.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified no visible damage can be seen on the implants.Implants are covered in bio-debris.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall sizing of the right total hip arthroplasty appears appropriate.Osteopenia is present.Loosening of the acetabular component is identified on the axial ct images only.Fracture of the anterior and posterior column of the acetabulum as well as the greater trochanter.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.

Event Description

No further information at the time of this report.

• Brand Name: G7 SCREW 6.5MM X 25MM
• 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: 17169583
• MDR Text Key: 317533304
• Report Number: 0001825034-2023-01383
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527461
• UDI-Public: (01)00880304527461(17)311112(10)7140810
• 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: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• 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: 010000998
• Device Lot Number: 7140810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2021
• 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): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 53 KG