MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 4 HOLE SHELL 58MM G; PROSTHESIS, HIP

Catalog Number	110010247
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 30103607 item name g7 vit e neutral lnr 36mm g lot # 66522413.G2: foreign: new zealand.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision procedure 5 months post implantation due to an anterior dislocation.Patient's soft tissue bulk had made initial approach difficult and cup version was also not ideal.There is no further information available at the time of this report.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h6 h11.Visual examination of the provided pictures identified the explanted device but could not be used to confirm the complaint.Device not returned, further analysis cannot be made.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.

• Brand Name: G7 OSSEOTI 4 HOLE SHELL 58MM G
• 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: 21575727
• Report Number: 0001825034-2025-00644
• Device Sequence Number: 20900845
• Product Code: LPH
• UDI-Device Identifier: 00887868355912
• UDI-Public: (01)00887868355912(17)340215(10)66440575
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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 Catalogue Number: 110010247
• Device Lot Number: 66440575
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown