MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT 360 TIB AUG 75X5MM M; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown femoral component.Unknown tibial tray.Unknown tibial bearing.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04936.
Event or Problem Description
It was reported that the tibial augment screws could not be tightened to the tibial base.The screws ran diagonally and would become stuck.The screws could not be removed without force from the screwdriver.The surgery was completed by fixing the augment with a screw and cement.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D11: 32-360298 unknown lot vgd 360 tib / fem coin diver g3: foreign country: germany complaint sample was evaluated and the reported event was not confirmed.Visual examination of the provided photos indicates that an attempt was made to insert the product.There are signs of biological materials on the photographed screw.The device history record was reviewed and no discrepancies were found.Root cause was unable to 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04936.
Event or Problem Description
It was reported that the tibial augment screws could not be tightened to the tibial base.The augment screw was running diagonally into the augment and not providing fixation with the tibial base.The screw was removed with force using the screwdriver as it was stuck.Another augment was opened from which a screw was removed, this screw was then implanted into the patient.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: BMT 360 TIB AUG 75X5MM M
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9262869
• Report Number: 0001825034-2019-04935
• Device Sequence Number: 17076460
• Product Code: JWH
• UDI-Device Identifier: 00880304481602
• UDI-Public: (01)00880304481602
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 185224
• Device Lot Number: 097180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention