MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 75MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 medical devices: vanguard cr ilok fem-lt 70 catalog#: 183032 lot#: j7621017; vgd ve as tib brg 75x10mm catalog#: ve189080 lot#: 64952250.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 patient was revised approximately two months post-implantation due to locking back backing out.No additional patient consequences were reported.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned locking bar identified signs of implantation and use in the form of nicks, gouges, and scratches.The tab on the implant was also found to be bent.Device history record was reviewed and no discrepancies were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.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.

• Brand Name: BIOMET CC CRUCIATE TRAY 75MM
• Common Device Name: PROSTHESIS, KNEE
• 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: 18944476
• Report Number: 0001825034-2024-00739
• Device Sequence Number: 15505015
• Product Code: JWH
• UDI-Device Identifier: 00887868247972
• UDI-Public: (01)00887868247972(17)320914(10)J7335025
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141234
• Device Lot Number: J7335025
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male