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

Catalog Number 010000812

Device Problem Difficult to Insert (1316)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 316663293
• Report Number: 0001825034-2023-01288
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526037
• UDI-Public: (01)00880304526037(17)250226(10)6751535
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 010000812
• Device Lot Number: 6751535
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 06/07/2023
• Supplement Dates FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male