MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 50MM D; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left hip arthroplasty.Subsequently, the patient was revised four (4) months post implantation due to the initial cup being too anteverted.The surgeon was concerned about potential dislocations.
Additional Manufacturer Narrative
(b)(4).D10: 010000856 g7 neutral e1 liner 36mm d 7151630, 010001000 g7 screw 6.5mm x 35mm 7536304, 650-0660 delta ceramic fem hd 36 -3mm 3105787.G2: foreign: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h3, h6 visual examination of the provided pictures identified an explanted liner and head, both components covered in bio debris.No further observations could be made based on the image alone.No image was provided of the cup.No product was returned; further visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided however were not reviewed as ap and lateral images would be required for the assessment of cup angles.The images were requested but were not provided.A definitive root cause cannot be determined.The placement of the implant is the surgeon's discretion based on patient anatomy.Anteversion of the implant could not be confirmed based on available information.This complaint cannot be confirmed.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.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 50MM D
• 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: 20622768
• Report Number: 0001825034-2024-02610
• Device Sequence Number: 8749391
• Product Code: LPH
• UDI-Device Identifier: 00887868355875
• UDI-Public: (01)00887868355875(17)340409(10)66519791
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 110010243
• Device Lot Number: 66519791
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 36 YR
• Patient Sex: Female