MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 4 HOLE SHELL 56MM F; PROSTHESIS, HIP

Catalog Number	110010246
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 suffered a bone fracture during preparation of the acetabulum.The cup was placed initially but as there was not sufficient fixation, they place another cup for better fixation on the bone.There is no further 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/corrected.Updated: b4, b5, g3, g6, h2, and h11.
Event or Problem Description
It was reported that the patient suffered an acetabular fracture during preparation of the acetabulum.The procedure was eventually completed using another device.There is no further information available at the time of this report.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d4; g3; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.The complaint cannot be confirmed.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 56MM 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: 21662325
• Report Number: 0001825034-2025-00771
• Device Sequence Number: 8737792
• Product Code: LPH
• UDI-Device Identifier: 00887868355905
• UDI-Public: (01)00887868355905(17)331101(66018444)
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2025

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: Health Professional
• Device Catalogue Number: 110010246
• Device Lot Number: 66018444
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 03/18/2025; 05/23/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/15/2025; 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown