MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-RT 67.5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent an initial right total knee arthroplasty performed.Subsequently, the patient underwent a manipulation under anesthesia approximately 2 months post implantation.No further complications have been reported and patient remains satisfied.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 189103 vngd ant stab brg 13x79, lot#: 408490.Mdr: 0001825034-2023-00420.Additional associated products: 141314 biomet finned pri stem 40mm, lot#: 239970; 141215 biomet ilok pri tib tray 79mm, lot#: 501280; 184766 series a pat std 34 3 peg, lot#: 338010.

• Brand Name: VANGUARD CR ILOK FEM-RT 67.5
• 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: 16459731
• Report Number: 0001825034-2023-00419
• Device Sequence Number: 12390804
• Product Code: HRY
• UDI-Device Identifier: 00880304270428
• UDI-Public: (01)00880304270428(17)320310(10)183010
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183010
• Device Lot Number: J7215821
• 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: 02/05/2023
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White