MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT 360 TIB TRAY 71MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.The locking bar is compatible with the tibial tray it is packaged with; however, the associated products were not provided.Unable to perform a complete compatibility check.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that a total knee arthroplasty was performed with vanguard 360.During procedure, the surgeon tried to insert locking bar to tibial plate.However, he was unable to insert it firmly.Subsequently, another locking bar was used to complete the procedure.No consequences or impact to the patient.

• Brand Name: BMT 360 TIB TRAY 71MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10718840
• Report Number: 0001825034-2020-03874
• Device Sequence Number: 3526508
• Product Code: JWH
• UDI-Device Identifier: 00880304481428
• UDI-Public: (01)00880304481428(17)281203(10)354840
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2020

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 Model Number: N/A
• Device Catalogue Number: 185203
• Device Lot Number: 354840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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