MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 56F; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported during surgery that while trying to set up the implant on the back table only two of the shells screw caps were able to be removed.The third screw cap stripped out.Two people in the sterile field attempted to remove and the correct 3.5 hex screwdriver from the g7 tray was used.Another cup was used to complete the procedure.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; d4; g3; h2; h3; h4; h6.Product was returned and evaluated.Visual examination of the returned product identified scratches to the shell anodized rim face.The apical hole plug was not returned.One screw hole plug was returned loose and undamaged, one screw was removed in the field and partially reassembled into the shell, and one screw was returned fully assembled into the shell.Assembled hole plug hex was stripped.Damage showed deformation, burrs, and gouges.Plug was unable to be removed during review for further evaluation.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Medical records were not provided.A definitive root cause cannot be determined.This complaint was confirmed based on the returned device.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 PPS LTD ACET SHELL 56F
• Common Device Name: PROSTHESIS, HIPS
• 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: 21242547
• Report Number: 0001825034-2025-00201
• Device Sequence Number: 8605544
• Product Code: PBI
• UDI-Device Identifier: 00880304524248
• UDI-Public: (01)00880304524248(17)340703(10)J7783963
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 010000665
• Device Lot Number: J7783963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2024
• 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
• Patient Sex: Unknown