MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 32MM G; PROSTHESIS, HIP

Catalog Number	010000812
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01289.D10: cat #: 110017107 / g7 finned 4 hole shell 60g / lot #: 7173931; cat #: 010000937 / g7 hi-wall e1 liner 36mm g / lot #: 6999200.G2: mexico.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that during a procedure, the liners failed to assemble into the cup after multiple attempts with multiple products.Because of this, the surgeon terminated the procedure, removed the prosthesis and closed leaving the hip without implanted components.No further information is available at this time.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this report is a duplicate of 0001825034-2023-01285.  the initial report was forwarded in error and should be voided.If additional information is to be received concerning the reported event, a supplemental mdr will be submitted under 0001825034-2023-01285.
Event or Problem Description
Upon receipt of additional information, it was determined this report is a duplicate of 0001825034-2023-01285.  the initial report was forwarded in error and should be voided.If additional information is to be received concerning the reported event, a supplemental mdr will be submitted under 0001825034-2023-01285.

• Brand Name: G7 HI-WALL ARCOMXL LNR 32MM G
• 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: 17074831
• Report Number: 0001825034-2023-01288
• Device Sequence Number: 17814675
• Product Code: PBI
• UDI-Device Identifier: 00880304526037
• UDI-Public: (01)00880304526037(17)250226(10)6751535
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 06/07/2023

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: Health Professional
• Device Expiration Date: 02/26/2025
• Device Catalogue Number: 010000812
• Device Lot Number: 6751535
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male