MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT 360 TIB AUG 71X10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a right knee revision approximately twenty-two months post implantation due to pain.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01593, 0001825034-2022-01594, 0001825034-2022-01595, 0001825034-2022-01596, 0001825034-2022-01597, and 0001825034-2022-01598.Medical devices: bmt 360 tib aug 67x10mm catalog#: 185232 lot#: 622080.Bmt 360 tib lg cruciate wing catalog#: 185651 lot#: 160950.Bmt splined knee stm v2 18x80 catalog#: 148308 lot#: 710510.Bmt 360 tib tray 67mm catalog#: 185202 lot#: 718090.Vngd ssk ps tib brg 18x63/67 catalog#: 185068 lot#: 845430.Vanguard cr ilok fem-rt 62.5 catalog#: 183006 lot#: 846430.Foreign source: australia.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01592, 0001825034-2022-01593, 0001825034-2022-01594, 0001825034-2022-01595, 0001825034-2022-01596, 0001825034-2022-01597, 0001825034-2022-01598, 0001825034-2022-01917, 0001825034-2022-01918, and 0001825034-2022-01919.D10 medical devices: bmt 360 tib aug 71x10mm, catalog#: 185233, lot#: 956120.Bmt 360 tib lg cruciate wing, catalog#: 185651, lot#: 805380.Bmt splined knee stm v2 18x40, catalog#: 148293, lot#: 998960.Bmt 360 tib tray 71mm, catalog#: 185203, lot#: 502940.Vngd ssk psc tib brg 14x71/75, catalog#: 183884, lot#: 820100.Vngd ssk 360 femur l 67.5, catalog#: 185285, lot#: 6668552.Bmt 360 2.5mm offset adapter, catalog#: 185210, lot#: 136930.Bmt splined knee stm v2 18x40, catalog#: 148293, lot#: 998960.Bmt 360 2.5mm offset adapter, catalog#: 185210, lot#: 057070.Series a pat thn 34 3 peg, catalog#: 184786, lot#: 512610.
Event or Problem Description
It was reported the patient underwent a left knee revision approximately twenty-two months post implantation due to pain.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 AUG 71X10MM
• 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: 14986806
• Report Number: 0001825034-2022-01592
• Device Sequence Number: 11166314
• Product Code: JWH
• UDI-Device Identifier: 00880304481688
• UDI-Public: (01)00880304481688(17)270830(10)970810
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 11/10/2022

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: 185233
• Device Lot Number: 970810
• 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: 06/16/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 10/31/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/23/2022; 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2017
• 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; SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown