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

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during surgery that the liner was unable to be seated into the shell.The surgeon indicated the initial insertion was unsuccessful due to soft tissue between the liner and shell.The high wall liner and soft tissue was removed, and the surgeon tried to re-insert the liner.The liner did not fully seat sitting proud approximately 1mm.The surgeon removed the liner and opened a new liner and inserted into the shell successfully.
Additional Manufacturer Narrative
(b)(4).D10: unknown 4 hole 58mm g7 osseoti shell unknown.G2: foreign: australia.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h3, h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The root cause is attributed to user error, and it is noted there was soft tissue between the shell and the liner.As per g7 acetabular system surgical technique it states, "ensure the interior of the shell is dry and free of debris, overhanging soft tissue, and bone." 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: 20914239
• Report Number: 0001825034-2024-02922
• Device Sequence Number: 7824348
• Product Code: PBI
• UDI-Device Identifier: 00880304527126
• UDI-Public: (01)00880304527126(17)281201(10)7665677
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121874
• 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
• Report Date (Section B): 04/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 7665677
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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 NARRATIVE
• Patient Sex: Unknown