MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM G; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 51-116160 tprlc 133 mp type1 bm so 16.0 7560160.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
It was reported that the patient underwent a primary hip arthroplasty.Subsequently, the patient was revised nearly one (1) month post implantation due to dislocation due to horizontal offset deficiency.The stem and head were explanted.
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: d1, d2, d4, g3, g4, g6, h2, h4.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h3, h6, h10.Visual examination of the provided picture identified the stem and head components which have been explanted and are covered in biodebris.No other observations could be made regarding the stem component.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ap pelvis demonstrates right total hip arthroplasty without radiolucency.No acute fracture.Moderate to severe left hip degenerative change.No hardware failure or loosening.A definitive root cause cannot be determined.During follow-up it was noted the surgeon put the dislocation down to the inadequate stem offset.The stem with standard offset was removed and a high offset stem was placed.Unable to confirm complaint.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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: G7 HI-WALL E1 LINER 36MM G
• 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: 20744364
• Report Number: 0001825034-2024-02756
• Device Sequence Number: 18236788
• Product Code: PBI
• UDI-Device Identifier: 00880304527126
• UDI-Public: (01)00880304527126(17)280704(10)7554411
• 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: 2024
• 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): 02/28/2025

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 010000937
• Device Lot Number: 7554411
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 12/08/2024; 02/27/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/02/2025; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2023
• 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; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 110 KG