MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN TRABECULAR METAL CR MONOBLOCK TIBIAL COMPONENT: YELLOW, SIZE 3 C-H, 12MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet and 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 tech noticed a hole in the packaging when the implant was opened.Another implant was used to complete the surgery.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Visual evaluation of the provided photos and returned product found puncture marks in the inner foil lid.Sterility is considered not breached as no damage to the outer cavity was reported.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.Upon reassessment of the reported event, it was determined to be not reportable as sterility was not breached.The initial report should be voided.
Event or Problem Description
No further information at the time of this report.

• Brand Name: NEXGEN TRABECULAR METAL CR MONOBLOCK TIBIAL COMPONENT: YELLOW, SIZE 3 C-H, 12MM
• Common Device Name: PROSTHESIS, KNEE
• 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: 19191284
• Report Number: 0001822565-2024-01418
• Device Sequence Number: 7620785
• Product Code: MBH
• UDI-Device Identifier: 00889024310018
• UDI-Public: (01)00889024310018(17)260505(10)64983244
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K031462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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: 05/05/2026
• Device Model Number: N/A
• Device Catalogue Number: 00588604312
• Device Lot Number: 64983244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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