MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD BMT 360 TIB LG CRUCIATE WING; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices -series a pat thin 37x8.6 3 peg catalog #: 184788 lot #: 290860; bmt splined knee stm 14x80 catalog #: 141614 lot #: 263030; bmt 360 tib 5.0 offset adapter catalog #: 185211 lot #: 162500; vngd ant stblzd brg 12x75 catalog #: 189082 lot #: 581300 report source - foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was not returned, because of hospital policy.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 according to the surgeon, the knee was unstable with tibial components showing increased hot spots in a scan.Patient was revised due to the instability.Attempts have been made, but there is no additional information at this time.
Event or Problem Description
Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.Please void report.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.Please void report.

• Brand Name: VANGUARD BMT 360 TIB LG CRUCIATE WING
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12237908
• Report Number: 0001825034-2021-02191
• Device Sequence Number: 14664649
• Product Code: JWH
• UDI-Device Identifier: 00880304525764
• UDI-Public: (01)00880304525764(17)261205(10)711840
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 11/30/2021

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: 185651
• Device Lot Number: 711840
• 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: 07/01/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose