MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM D; 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	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: (b)(6) ti low profile screw 6.5x20mm 2019100385, (b)(6) g7 pps ltd acet shell 50d 7698004, (b)(6) tprloc 12/14 por 7.5x135 7476036, (b)(6) ti low profile screw 6.5x25mm 2018111414, (b)(6) 36mm i.D.Size d 10â° liner 66199070, (b)(6) bone screw self-tapping 6.5 mm dia.20 mm length 65857592.G2: foreign: poland.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.
Event or Problem Description
It was reported that the liner did not seat inside the g7 acetabulum.The initial cup was able to be implanted, and a new liner was used to complete the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated.Visual examination of the returned product identified no damage to the locking feature or the outer radius of the device.There were indentations to the scallops around the lip under the locking feature.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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 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 D
• 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: 20952552
• Report Number: 0001825034-2024-02975
• Device Sequence Number: 15565441
• Product Code: PBI
• UDI-Device Identifier: 00880304527096
• UDI-Public: (01)00880304527096(17)281013(10)7619739
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 03/03/2025

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: 010000934
• Device Lot Number: 7619739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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