MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 35MM; PROSTHESIS, HIP

Catalog Number	010001000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Periprosthetic fracture (4902)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 110031010 lot# 66528796 28mm i.D.40mm o.D.Size d bearing.Cat# 110024462 lot # 66734077 g7 dual mobility liner 40mm d.Cat# 59035-16 lot# 518943 steckkugeln biolox delta head l.Cat# 111-242-351 lot# 86adc evolve stem- cemented.Cat# 111-162-002 lot # 84e0c-23 evolve distal centralizer sz wide.Cat# 13a2100 lot# ac4052 cemex cement.Cat# t860010 lot# 8624231 nanogel.G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent a revision procedure approximately one week post implantation due to pain.Radiographic imaging displayed a bony acetabular fracture.Attempts have been made, and no further information has been provided.
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; h10.Visual examination of the provided pictures identified the explanted screws, shell, liner, and head.Devices were covered in bio-debris.No further evaluation could be made from the provided pictures.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: fracture of the bony acetabulum at the position of the 2nd lower most screw in the acetabulum.The bone fragments are separated by approximately 18mm, the bone fragment is displaced posteriorly.Increasing hip pain 7 days after tha.Xray and ct scan revealed fracture of the acetabulum.It was identified that zimmer biomet bearing was implanted with a competitor device.As per ifu, "dual mobility hip bearings should only be used with compatible components that are currently licensed/cleared for marketing in the country of use." it is unknown if these off-label usage may have caused or contributed to the reported events.A definitive root cause cannot be identified.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 SCREW 6.5MM X 35MM
• 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: 22563649
• Report Number: 0001825034-2025-02186
• Device Sequence Number: 9347594
• Product Code: PBI
• UDI-Device Identifier: 00880304527485
• UDI-Public: (01)00880304527485(17)340210(10)7717023
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 11/03/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 010001000
• Device Lot Number: 7717023
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2024
• 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 Sex: Female
• Patient Weight: 60 KG