MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD PS TIB BRG; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Joint Laxity (4526)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure twenty months post implantation due to instability in knee.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: bmt 360 7.5mm offset adapter catalog # 185212 lot # 391690.Bmt 360 tib tray 63mm catalog # 185201 lot # 737090.Bmt 360 tib aug 63x10mm catalog # 185231 lot # 138590.Bmt 360 tib sm cruciate wing catalog # 185650 lot # 547810.Bmt splined knee stm v2 17x80 catalog # 148307 lot # 698780.Vngd ps open intl fem rt 60 catalog # 183104 lot # j3862188.H3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.No problem found with zimmer biomet device.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.No problem found with zimmer biomet device.The initial report was forwarded in error and should be voided.

• Brand Name: VNGD PS TIB BRG
• 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: 17408972
• Report Number: 0001825034-2023-01742
• Device Sequence Number: 7090501
• Product Code: JWH
• UDI-Device Identifier: 00880304271906
• UDI-Public: (01)00880304271906(17)221231(10)373410
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K023546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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 Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 183630
• Device Lot Number: 373410
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2017
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female