MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 36MM I; PROSTHESIS, HIP

Catalog Number	010000822
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: mexico.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 during the procedure, the liner was unable to be assembled with the shell.Another construct was used to complete the procedure.There was no harm or health consequences to the patient.Attempts have been made and no further information is available.
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.The following sections were updated/corrected updated: a2; a3; a4; b4; b5; b7; g3; h2.The investigation into the reported event is currently underway.Once the investigation is complete, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4; b5; d9; g3; h2; h3; h4; h6.Visual examination of the returned product identified scuffing to the od and found the locking feature to be deformed with shavings visible.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Radiographs were provided and were not reviewed by a health care professional as it would not enhance the investigation.There was 1 image of a full construct, but it is unsure if it was the final construct or if it was the construct the surgeon was not able to fit/mate.The complaint could not be confirmed.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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: G7 HI-WALL ARCOMXL LNR 36MM I
• 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: 19657352
• Report Number: 0001825034-2024-01748
• Device Sequence Number: 15165741
• Product Code: PBI
• UDI-Device Identifier: 00880304526129
• UDI-Public: (01)00880304526129(17)240821(10)6604666
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2024

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 Expiration Date: 08/21/2024
• Device Catalogue Number: 010000822
• Device Lot Number: 6604666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 09/12/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/22/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 120 KG