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

Catalog Number	010000999
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2024-00241.0001825034-2024-01928.0001825034-2024-01929.D10: cat #: 00811400000 / femoral stem 12/14 neck taper std.Offset size 0 105 mm stem length / lot #: 66225575.Cat #: 110024463 / g7 dual mobility liner 42mm e / lot #: 151700.Cat #: 110010244 / g7 osseoti 3 hole shell 52mm e / lot #: 66195140.Cat #: 010000998 / g7 screw 6.5mm x 25mm / lot #: 7612314.G2: australia.Visual examination of the provided pictures identified the cup with bio debris on the cup and stem, no other information can be obtained from the images.The complaint is unable to be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.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 or Problem Description
It was reported a patient underwent a hip revision approximately four months post implantation due to a dissociation and peri-prosthetic fracture.The stem, liner, bearing, and head were removed and replaced.Attempts have been made and no further information is available.

• Brand Name: G7 SCREW 6.5MM X 30MM
• Common Device Name: 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: 20852319
• Report Number: 0001825034-2024-02864
• Device Sequence Number: 12772506
• Product Code: PBI
• UDI-Device Identifier: 00880304527478
• UDI-Public: (01)00880304527478(17)331016(10)7633835
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 010000999
• Device Lot Number: 7633835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female