MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 60MM G; PROSTHESIS, HIP

Catalog Number	110010268
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign source: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that debris was found in the sterile packaging with the g7 shell.Product was not used and discarded.An additional back up product was used; there was no patient harm or injury.No additional information available.
Additional Manufacturer Narrative
Visual evaluation of the provided photographs identified the packaging has been opened and no debris is visible in sterile packaging.Reported event could not be confirmed.Review of the device history records identified no related deviations or anomalies during manufacturing related to the reported event.The root cause of the reported event 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 information on the reported event.

• Brand Name: G7 OSSEOTI MULTIHOLE 60MM 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: 15327054
• Report Number: 0001825034-2022-01995
• Device Sequence Number: 6485406
• Product Code: LPH
• UDI-Device Identifier: 00880304544437
• UDI-Public: (01)00880304544437(17)290301(10)6497866
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140669
• 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): 09/15/2022

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 Catalogue Number: 110010268
• Device Lot Number: 6497866
• Was Device Available for Evaluation?: No
• 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: 08/08/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• 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: Unknown