MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIT E 10DEG LNR 36MM E; PROSTHETIC, HIP

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	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after implanting the multihole cup, 10 degree liner would not lock into the cup.Another liner was attempted but would also not lock into the cup so the doctor decided to cement the liner to cup.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 30123605, g7 vit e high wall lnr 36mm e, lot number: 64545912, unknown cup.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01035.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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.
Event or Problem Description
There is no additional information available at the time of this report.

• Brand Name: G7 VIT E 10DEG LNR 36MM E
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16733560
• Report Number: 0001822565-2023-01036
• Device Sequence Number: 17819972
• Product Code: LPH
• UDI-Device Identifier: 00889024520196
• UDI-Public: (01)00889024520196(17)241231(10)64610528
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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 Expiration Date: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 30113605
• Device Lot Number: 64610528
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2019
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H10
• Patient Sex: Prefer Not To Disclose