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

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 08/02/2022

Event Type  Injury  

Event Description

It was reported that patient underwent a hip revision approximately 2.5 months post implantation due to a trochanteric avulsion fracture and loss of fixation with vertical migration of the acetabular cup.The stem remained intact and all other components were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: 00787101360 ¿ femoral stem ¿ 65192918, 00877502802 ¿ biolox femoral head ¿ 3085081.Foreign source: australia.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.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 - 2022 - 01949, 0001825034 - 2022 - 01950, 0001825034 - 2022 - 01951, 0001825034 - 2022 - 01953.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6 medical records were provided and reviewed by a health care professional.Review of the available records identified the following: issue is loss of cup fixation, now vertical, hinging on superior screws.Also troch avulsion fracture, denies falls/stumbles, not much pain in hip.No observation of periacetabular or pelvic fracture.Review of the device history record(s) identified no 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: 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: 15296493
• MDR Text Key: 298629534
• Report Number: 0001825034-2022-01952
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527461
• UDI-Public: (01)00880304527461(17)310608(10)7042298
• 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: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• 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: 7042298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 45 KG