MAUDE Adverse Event Report: . G7 10 DEG ARCOMXL LINER 32MM C; PROSTHESIS, 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	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign: country: (b)(6).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 the doctor impacted the liner into the cup and they did not match correctly.There was no delay or patient damage.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
Additional Manufacturer Narrative
Product was returned and evaluated.A visual examination of the returned product identified tool marks on the sidewall of the liner.There were scallops present around the tool marks which had an indentation across the surface close to the outer radius.A light scuff and inclusion were also observed in the outer radius.The inclusion could not be felt to the touch.Medical records were not provided.A review of the device history records identified no related deviations or anomalies during manufacturing.A compatibility check could not be completed due to insufficient information.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 further event information is available at the time of this report.

• Brand Name: G7 10 DEG ARCOMXL LINER 32MM C
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): .; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13505090
• Report Number: 0001825034-2022-00289
• Device Sequence Number: 3953150
• Product Code: PBI
• UDI-Device Identifier: 00880304525221
• UDI-Public: (01)00880304525221(17)250714(10)6827290
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2023

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: 07/14/2025
• Device Model Number: N/A
• Device Catalogue Number: 010000769
• Device Lot Number: 6827290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/31/2022
• Supplement Date Received by Manufacturer: 04/13/2022; 07/19/2023
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 04/15/2022; 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2020
• 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
• 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
• Patient Sex: Unknown