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

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-01195, 0001825034-2021-01196, 0001825034-2021-01197, 0001825034-2021-01202, 0001825034-2021-01203, 0001825034-2021-01204.Medical product: vngd ssk psc tib brg 20x79/83, item# 183910, lot# 325220; biomet tibial locking bar, item# 141205, lot# 253630; bmt 360 tib tray 83mm, item# 185206, lot# 693020; series a pat std 37 3 peg, item# 184768, lot# 449350; vanguard cr ilok fem-rt 72.5, item# 183013, lot# j3762484; bmt splined knee stm v2 21x40, item# 148296, lot# 119560.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 a patient was revised approximately one-year post implantation due to unknown reasons.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause 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 further event information available at the time of this report.

• Brand Name: BMT 360 TIB SM CRUCIATE WING
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11716080
• Report Number: 0001825034-2021-01200
• Device Sequence Number: 17204671
• Product Code: MBH
• UDI-Device Identifier: 00880304525771
• UDI-Public: (01)00880304525771(17)270204(10)502160
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 185650
• Device Lot Number: 502160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 06/02/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention