MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 32MM E; PROSTHESIS, HIP

Catalog Number	010000927
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the liner would not assemble with the shell.Another liner was used to complete the procedure.There was no impact or health consequences to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02616.D10: cat #: 010000663 / g7 pps ltd acet shell 52e / lot #: 7440497.G2: poland.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified their liner locking feature has been deformed and shaved.There is no visible damage to the shell.It is unknown if the damage occurred prior to or during the assembly attempts.Complaint confirmed based on the evaluation of the returned product.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.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 HI-WALL E1 LINER 32MM E
• 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: 18606416
• Report Number: 0001825034-2024-00203
• Device Sequence Number: 9128528
• Product Code: PBI
• UDI-Device Identifier: 00880304527034
• UDI-Public: (01)00880304527034(17)270517(10)7264148
• 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): 02/28/2024

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: Health Professional
• Device Catalogue Number: 010000927
• Device Lot Number: 7264148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• 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: 01/24/2024
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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 H10 NARRATIVE.
• Patient Sex: Unknown