MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 54MM F; PROSTHESIS, HIP

Catalog Number	110010265
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hematoma (1884); Joint Dislocation (2374); Medical device site infection (4845); Periprosthetic fracture (4902)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had an initial left total hip arthroplasty performed.Subsequently, the patient was revised approximately 1 (one) month later due to periprosthetic acetabular fracture and recurrent dislocation.During the revision, a large hematoma was evacuated.The previous implant was removed without difficulty.The acetabulum was impacted with allograft, and a definitive cup-cage construct was implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: item# 010000997, g7 screw 6.5mm x 20mm, lot# 7868289.Item# 010000999, g7 screw 6.5mm x 30mm, lot# 7633835.Item# 010000998, g7 screw 6.5mm x 25mm, lot# 7852535.Item# 010000999, g7 screw 6.5mm x 30mm, lot# 7633837.Item# 110031012, vivacit-e dm bearing 28x44mm, lot# 66555066.G2 foreign: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information 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: d4; g3; h3; h4; h6; h10.Visual examination of the provided pictures identified the shell and liner explanted along with 2x screws, all components are covered in biodebris.No other observations could be made based on the image alone.No product was returned; further visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient had a initial left tha.Initial op notes were not provided.Patient had a revision due to periprosthetic fracture and recurrent dislocation.A large hematoma was evacuated with no sign of infection.Acetabular and femoral components were removed without complication and new shell placed and reinforced with acetabular cage short flange and new stem placed, good range of motion and leg length.No other complications noted.A definitive root cause cannot be determined.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 MULTIHOLE 54MM F
• 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: 24303607
• Report Number: 0001825034-2026-00314
• Device Sequence Number: 5215055
• Product Code: LPH
• 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: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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 Catalogue Number: 110010265
• Device Lot Number: 65871897
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 122 LB