MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIT E 10DEG LNR 40MM F; PROSTHESIS, HIP

Catalog Number	30114006
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the surgeon was not able to assemble the liner with the cup.Another device was opened and used to complete the procedure.There was no harm or health consequences to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).G2: canada.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of the returned product.A g7 vit e 10deg lnr 40mm f, part # 30114006 from lot 65056170, was returned and evaluated against the complaint.There are no identifiers on the liner to be verified.Visual inspection found the barb to be scraped and deformed.Scratches and scuffs are present on the outer radius.The sidewall has been gouged.Metal particulates have become embedded in the material.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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 available at the time of this report.

• Brand Name: G7 VIT E 10DEG LNR 40MM F
• Common Device Name: PROSTHESIS, 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: 17169409
• Report Number: 0001822565-2023-01661
• Device Sequence Number: 7201101
• Product Code: LPH
• UDI-Device Identifier: 00889024520257
• UDI-Public: (01)00889024520257(17)260412(10)65058170
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: 04/12/2026
• Device Catalogue Number: 30114006
• Device Lot Number: 65056170
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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: Unknown