MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 52MM E; 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	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when opening the g7 cup, the surgical technician went to remove the screw cap hole cover and was unable to remove it.It appeared that the whole plug cover was stripped.No known impact or consequences to the patient.
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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, g3, g6, h2, h3, h4, h6 visual examination of the returned product identified scratches are to shell anodized rim face and inner spherical surface.Apical hole plug and (2) screw hole plugs were returned loose and undamaged.One remaining screw hole plug was returned fully assembled in the shell and hex was confirmed to be 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 related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.The complaint is confirmed based on the returned product evaluation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 52MM E
• 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: 21937981
• Report Number: 0001825034-2025-01269
• Device Sequence Number: 7837469
• Product Code: LPH
• UDI-Device Identifier: 00887868355882
• UDI-Public: (01)00887868355882(17)350115(10)67096416
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: 110010244
• Device Lot Number: 67096416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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